Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12614000090617
Ethics application status
Approved
Date submitted
10/01/2014
Date registered
23/01/2014
Date last updated
4/07/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Confirmatory pharmacokinetic study of paracetamol and phenylephrine hydrochloride in healthy adults
Query!
Scientific title
Comparative, randomized, single dose, three-period, cross-over open label study to evaluate the pharmacokinetic parameters of a new formulation of paracetamol and phenylephrine tablets (Maxiclear) relative to an oral administration of fixed dose combination of paracetamol 1000 mg and phenylephrine 10 mg and relative to an oral administration of phenylephrine 10 mg tablets alone, in healthy adults under fasting conditions
Query!
Secondary ID [1]
283889
0
NIL
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
AFT-MXCF-02
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cold & Flu
290874
0
Query!
Condition category
Condition code
Infection
291305
291305
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Drug & Dose: Combinations of Paracetamol 1000mg with Phenylephrine 5mg and with Phenylephrine 10 mg
Dose frequency: Single dose
Duration Administration: Single dose
Mode Administration:Oral tablet
Washout between treatments = 7 days
Treatment arms: 3
Arm 1: Paracetamol 1000 mg and Phenylephrine 5 mg
Arm 2: Paracetamol 1000 mg and Phenylephrine 10 mg
Arm 3: Phenylephrine 10 mg
All participants complete intervention Arms 1 and 2 and control arm 3
Query!
Intervention code [1]
288565
0
Treatment: Drugs
Query!
Comparator / control treatment
Drug & Dose: Phenylephrine 10 mg
Dose frequency: Single dose
Duration Administration: Single dose
Mode Administration:Oral tablet
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
291229
0
Evaluation of pharmacokinetic paramaters [Cmax, AUC, Tmax, T 1/2] of Phenylephrine hydrochloride
Assessed by measurement of plasma drug concentrations
Query!
Assessment method [1]
291229
0
Query!
Timepoint [1]
291229
0
Single dose study measuring plasma concentrations over 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 6, 8, 10 and 12 hours after study drug administration
Query!
Secondary outcome [1]
306297
0
Safety will be evaluated during each study period, and for 7 days following study drug administration.
An acute safety evaluation will be performed during each study period by recording spontaneously reported adverse events and by clinical assessments, including measurements of blood pressure and heart rate.
Known phenylephrine hydrochloride adverse effects (i.e increased systolic and diastolic blood pressure, palpitations, headache, vomiting, nervousness), and known paracetamol adverse effects (i.e. clinical evidence of hepatotoxicity) will be compared between groups.
Adverse events will continue to be assessed up to 7 days after the last dose of the study medication by spontaneous reporting and at a final follow-up phone call.
Query!
Assessment method [1]
306297
0
Query!
Timepoint [1]
306297
0
Single dose study measuring plasma concentrations over 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 6, 8, 10 and 12 hours after study drug administration
Safety will be evaluated during each study period, and for 7 days following study drug administration.
Query!
Eligibility
Key inclusion criteria
Healthy volunteers
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
40
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
pregnancy, nursing, drug abuse, smoking > 10 cigarettes per day, excess alcohol intake, prescription drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Pharmacokinetics
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
3/02/2014
Query!
Actual
14/04/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
22/04/2014
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
5742
0
Jordan
Query!
State/province [1]
5742
0
Query!
Funding & Sponsors
Funding source category [1]
288531
0
Commercial sector/Industry
Query!
Name [1]
288531
0
AFT Pharmaceuticals Ltd
Query!
Address [1]
288531
0
Level 1, 129 Hurstmere Rd, Takapuna, Auckland, 0622, New Zealand
Query!
Country [1]
288531
0
New Zealand
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
AFT Pharmaceuticals Ltd
Query!
Address
Level 1, 129 Hurstmere Rd, Takapuna, Auckland, 0622, New Zealand
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
287240
0
None
Query!
Name [1]
287240
0
none
Query!
Address [1]
287240
0
none
Query!
Country [1]
287240
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
290394
0
IPRC Institutional Review Board
Query!
Ethics committee address [1]
290394
0
172 Queen Rania St
PO Box 963166
Amman 11942
Query!
Ethics committee country [1]
290394
0
Jordan
Query!
Date submitted for ethics approval [1]
290394
0
20/01/2014
Query!
Approval date [1]
290394
0
13/03/2014
Query!
Ethics approval number [1]
290394
0
Query!
Summary
Brief summary
To measure the pharmacokinetics [how the body treats drugs] of phenylephrine in humans since this is still not well understood and to check this specifically for a tablet mixture of paracetamol and phenylephrine called Maxiclear.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
45470
0
Dr Dr.Naji Najib
Query!
Address
45470
0
International Pharmaceutical Research Center Queen Rania St - Sport City Circle PO Box 963166 Amman 11196
Query!
Country
45470
0
Jordan
Query!
Phone
45470
0
+962562764/51
Query!
Fax
45470
0
+96265627654
Query!
Email
45470
0
[email protected]
Query!
Contact person for public queries
Name
45471
0
Dr Hartley Atkinson
Query!
Address
45471
0
AFT Pharmaceuticals Ltd, Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Query!
Country
45471
0
New Zealand
Query!
Phone
45471
0
+6494880232
Query!
Fax
45471
0
+6494880234
Query!
Email
45471
0
[email protected]
Query!
Contact person for scientific queries
Name
45472
0
Dr Hartley Atkinson
Query!
Address
45472
0
AFT Pharmaceuticals Ltd, Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Query!
Country
45472
0
New Zealand
Query!
Phone
45472
0
+6494880232
Query!
Fax
45472
0
+6494880234
Query!
Email
45472
0
[email protected]
Query!
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.
Download to PDF