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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
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
Secondary ID [1] 283889 0
NIL
Universal Trial Number (UTN)
Trial acronym
AFT-MXCF-02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cold & Flu 290874 0
Condition category
Condition code
Infection 291305 291305 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 288565 0
Treatment: Drugs
Comparator / control treatment
Drug & Dose: Phenylephrine 10 mg
Dose frequency: Single dose
Duration Administration: Single dose
Mode Administration:Oral tablet
Control group
Active

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
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
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.
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.

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5742 0
Jordan
State/province [1] 5742 0

Funding & Sponsors
Funding source category [1] 288531 0
Commercial sector/Industry
Name [1] 288531 0
AFT Pharmaceuticals Ltd
Address [1] 288531 0
Level 1, 129 Hurstmere Rd, Takapuna, Auckland, 0622, New Zealand
Country [1] 288531 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals Ltd
Address
Level 1, 129 Hurstmere Rd, Takapuna, Auckland, 0622, New Zealand
Country
New Zealand
Secondary sponsor category [1] 287240 0
None
Name [1] 287240 0
none
Address [1] 287240 0
none
Country [1] 287240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290394 0
IPRC Institutional Review Board
Ethics committee address [1] 290394 0
172 Queen Rania St
PO Box 963166
Amman 11942
Ethics committee country [1] 290394 0
Jordan
Date submitted for ethics approval [1] 290394 0
20/01/2014
Approval date [1] 290394 0
13/03/2014
Ethics approval number [1] 290394 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45470 0
Dr Dr.Naji Najib
Address 45470 0
International Pharmaceutical Research Center Queen Rania St - Sport City Circle PO Box 963166 Amman 11196
Country 45470 0
Jordan
Phone 45470 0
+962562764/51
Fax 45470 0
+96265627654
Email 45470 0
iprc@iprc.com.jo
Contact person for public queries
Name 45471 0
Dr Hartley Atkinson
Address 45471 0
AFT Pharmaceuticals Ltd, Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Country 45471 0
New Zealand
Phone 45471 0
+6494880232
Fax 45471 0
+6494880234
Email 45471 0
hartley@aftpharm.com
Contact person for scientific queries
Name 45472 0
Dr Hartley Atkinson
Address 45472 0
AFT Pharmaceuticals Ltd, Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Country 45472 0
New Zealand
Phone 45472 0
+6494880232
Fax 45472 0
+6494880234
Email 45472 0
hartley@aftpharm.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary