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Trial registered on ANZCTR
Registration number
ACTRN12610000883011
Ethics application status
Approved
Date submitted
15/10/2010
Date registered
19/10/2010
Date last updated
20/10/2010
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulatons of darifenacin against the innovator darifenacin product in healthy volunteers.
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Scientific title
Bioequivalence assessment of generic darifenacin [Darisec(R - registered trademark) ] vs. innovator darifenacin [Enablex(R - registered trademak)] in healthy volunteers.
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Secondary ID [1]
252912
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None
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Universal Trial Number (UTN)
U1111-1117-4887
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Trial acronym
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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
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Condition category
Condition code
Other
258573
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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 admininstration of Darifenacin, Darisec(R - registered trademark) 7.5 mg p.o. , single dose, cross over study design with one week wash out period in between.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
Simultaneous administration of Darifenacin, Enablex(R - registered trademark) 7.5 mg p.o. single dose cross over study design with one week wash out period in between.
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Control group
Active
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Outcomes
Primary outcome [1]
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Area Under the Curve concentration of Darifenacin/time (AUC0-t and AUC0-inf).
Darifenacin plasma concentration will be measured with a Liquid Chromatography-Mass Spectrometry method and concentration vs. time curves will be plotted
Area Under the Curve (AUC0-t) will be calculated using the trapezoidal rule.
AUC0-inf will be calculated extrapolating the last cocentration 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 and 72 hours.
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Secondary outcome [1]
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Maximum concentration (Cmax).
Darifenacinn plasma concentration will be measured with a Liquid Chromatography-Mass Spectrometry method and concentration vs. time curves will be plotted
Peak concentration (Cmax) will be directly taken from the darifenacin plasma concentration vs. time curve.
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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 and 72 hours.
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Secondary outcome [2]
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Time to peak concentrarion (Cmax) .
It is measured on the abscissa from time 0 to the Cmax time.
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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 and 72 hours.
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Eligibility
Key inclusion criteria
Caucasians
BMI>18.5 and <29.9 kg/m2
Healthy based in medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
Able to comply wiht study procedures.
Able to give informed written consent for participation in the study.
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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 idiosyncratic reaciton to darifenacin or any related drug.
Resting heart rate > 70 bpm.
Pregnant or breast-feeding.
Ingestion of medicines at any time within 14 days before the inception of the trial.
A recent history of alcoholism (<2 years) or of moderate alcohol use (180 ml/day), or consumption of alcohol within 48 hours prior to the start of the study.
Smoker, more than 10 ciegarrettes per day.
Presence of clinically significant abnormal laboratory values during screening.
History of drug addiction or testing positive in pre-study drug scan.
Donation of blood (350 ml) within 90 days prior to receiving the study drug.
History of psychiatric disorder.
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Study design
Purpose of the study
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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)
Allocation was concealed using numbered containers.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computarised 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
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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
15/11/2010
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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 - Argentina.
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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. Artigas1632. 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]
257083
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Country [1]
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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 Investigaci?n. Universidad Catolica.
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Ethics committee address [1]
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8 de Octubre 2738. 11600 Montevideo
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Ethics committee country [1]
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Uruguay
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Date submitted for ethics approval [1]
259908
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Approval date [1]
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13/09/2010
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Ethics approval number [1]
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A.05.09.10
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Summary
Brief summary
The objective of the present trial is to assess the bioequivalence of a new formulation of extended release darifenacin -Darisec (R) 7.5 mg- vs. the innovator -Enablex(R) 7.5 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
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Susana Parrillo
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Address
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Hospital Italiano.
Br. Artigas1632.
cp 11600 Montevideo.
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Country
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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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Francisco E. Estevez-Carrizo
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Address
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Hospital Italiano.
Br. Artigas 1632.
cp 11600. Montevideo
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Country
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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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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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