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Trial registered on ANZCTR
Registration number
ACTRN12610000894099
Ethics application status
Approved
Date submitted
20/10/2010
Date registered
21/10/2010
Date last updated
21/10/2010
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparative evaluation of the absorption and disposition in the body of a generic formulation of darifenacin 15 mg against the innovator product in healthy fed volunteers.
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Scientific title
Realtive Bioavailability and pharmacokinetic profiling of a generic darifenacin formulation [Darisec(R - registered trademark) extended release 15 mg] vs. the innovator [Enablex(R - registered trademark) 15 mg] in healthy fed volunteers
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Secondary ID [1]
252925
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The trial does not have a secondary ID.
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Universal Trial Number (UTN)
U1111-1117-5341
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Trial acronym
None
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bioequivalence assessment between two formulations of darifenacin 15 mg.
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Condition category
Condition code
Other
258619
258619
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Simultaneous administration of Darifenacin, Darisec(R - registered trademark)15.0 mg p.o., single dose, crossover study design with one week washout periodo in between before moving over to the control treatment.
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Intervention code [1]
257447
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Treatment: Drugs
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Comparator / control treatment
Simultaneous administration of Darifenacin, Enablex (R - registered trademark) 15.0 mg p.o., single dose, crossover study design with one week washout periodo in between before moving over to the intervention goup treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Area Under the Curve (AUC) concentration of darifenacin/time (AUC0-t and AUC0-inf).
Darifenacin plasma concentration will be measured with Liquid Chromatography-Mass Spectromtry method and concentration vs. time curves will be plotted.
AUC0-t will be calculated using the trapezoidal rule.
AUC0-inf will be calculated extrapolating the last concentration point to infinity using the log-linear elimination rate constant method.
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Assessment method [1]
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Timepoint [1]
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0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.
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Primary outcome [2]
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Peak concentration (Cmax)
Darifenacin plasma concentration will be measured with Liquid Chromatography- Mass Spectrometry Method and concentration vs. time curves will be plotted.
Cmax will be taken directly from the darifenacin plasma concentration vs. time curve.
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Assessment method [2]
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Timepoint [2]
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0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.
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Secondary outcome [1]
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Time to Cmax (tmax).
Is the time elapsed from ingestion of darifenacin tablets to plasma peak concentration.
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Assessment method [1]
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Timepoint [1]
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0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.
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Secondary outcome [2]
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Absorption Rate Constant(Ka)
The absorption rate constant is the fractional rate of drug disappearance from the intestinal tract, measured in the log-linear phase of drug absorption.
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Assessment method [2]
266036
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Timepoint [2]
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0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.
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Secondary outcome [3]
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Elimination Rate Constant (Ke)
The elimiminaiton rate constant is the fractional rate of drug dissapearance from the peripheral compartment, measured in the log-linear phase of elimination.
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Assessment method [3]
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Timepoint [3]
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0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.
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Eligibility
Key inclusion criteria
Healthy caucasian male or female subjects 18 to 50 years of age (inclusive)
In good health, as determined by lack of clinically significant abnormalities at screening as judged by the physician.
Female subjects are required to use a medically accepted method of hormonal contraception or abstinence throughout the entire study period and for one week after the study is completed.
Body mass index within the range of 18.5 and 29.9 kg/m2 and weight at least 45 kg.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Known hypersensitivity or severe adverse event to darifenacin or similar drugs.
Urinary retention, narrow-angle glucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis, toxic megacolon.
Symptomatic hiatus hernia, erosive or symptomatic gastroesophageal reflux disease/heartburn (>2 days in a week), severe constipation, gastrointestinal obstructive disorder, and gastric retention.
Clinically significant cardiac abnormalities, fainting, low blood pressure upon standing, irregular heartbeats.
Acute or chronic bronchospastic disease (including athma and Chronic Obstructive Pulmonary Disease).
Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis).
Smokers of more than 5 cigarettes a week.
Regular use of any drugs known to induce or inhibit hepatic drug metabolism (particularly those that affect CYP2D6) within 30 days prior to each study drug administration.
Any surgical or medical condition wich might significantly alter the absorption, distribution, metabolism or excretion of drugs which may jeopardize participation in the study.
Immunodeficiency diseases, including a positive HIV (Elisa or Western blot) test result.
Positive hepatitis B Surface antigen (HBsAg) or Hepatitis C test result.
Drug or alcohol abuse within the 6 months prior to dosing.
Use of prescription drugs within 1 month prior to dosing, or over-the-counter medication (vitamine, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol and ibuprofen are acceptable.
Participation in any clinical investigation within 4 weeks prior to dosing.
Donation or loss of 400 ml or more of blood within 2 months prior to dosing.
Significant illness within 2 weeks prior to dosing.
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
University students and subjects from the general population will be invited to particpate in the study. After informed consent is signed, medical examination and labs screening ensues in order to prove the volunteer is healthy.
Once the volunteers passes clinical and laboratory check up, he is assigned to one tretment sequence.
Allocation will be concealed using numbered containers.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computarized sequence generation.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
Two-sequence, two period, balanced with administration of investigation products in fed conditions.
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Phase
Phase 1
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Type of endpoint/s
Bio-equivalence
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
6/12/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Uruguay
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State/province [1]
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Montevideo
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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ELEA S.A.C.I.F. y A.
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Address [1]
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Sanabria 2353 - C1417AZE - Ciudad de Buenos Aires.
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Country [1]
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Argentina
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Primary sponsor type
Commercial sector/Industry
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Name
Center for Clinical Pharmacology Research Bdbeq S.A.
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Address
Br. Artigas 1632, cp 11600, Montevideo.
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Country
Uruguay
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
257088
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Comite de Etica en la Investigacion. Universidad Catolica
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Ethics committee address [1]
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8 de Octubre 2801. cp 11600, Montevideo.
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Ethics committee country [1]
259917
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Uruguay
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Date submitted for ethics approval [1]
259917
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Approval date [1]
259917
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13/09/2010
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Ethics approval number [1]
259917
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A.04.09.10
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Summary
Brief summary
The objective of the present trial is to assess the bioequivalence and pharmacokinetic profile of a new extended release formulation of darifenacin [Darisec(R - registered trademark) 15 mg] vs. the innovator [Enablex(R - registered trademark) 15 mg]; both given orally, within 30 minutes of a high fat breakfast, to healthy volunteers.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
31809
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Country
31809
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Phone
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Fax
31809
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Email
31809
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Contact person for public queries
Name
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Francisco E. Estevez Carrizo, M.D.
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Address
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Center for Clinical Pharmacology Research Bdbeq S.A.; Hospital Italiano, Br. Artigas 1632. cp 11600 Montevideo.
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Country
15056
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Uruguay
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Phone
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+59824876288
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Susana Parrillo, M.D.
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Address
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Center for Clinical Pharmacology Research Bdbeq S.A.; Hospital Italiano, Br. Artigas 1632. cp 11600 Montevideo.
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Country
5984
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Uruguay
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Phone
5984
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+59824876288
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Fax
5984
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Email
5984
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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