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Trial registered on ANZCTR


Registration number
ACTRN12613000197730
Ethics application status
Approved
Date submitted
14/02/2013
Date registered
19/02/2013
Date last updated
28/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of the pharmacokinetics [the way the body handles drug] of paracetamol and phenylephrine in healthy adults
Scientific title
Randomised single dose two arm cross-over open label study to determine the bioavailability of paracetamol and phenylephrine tablets relative to concomitant administration of Sudafed Nasal Decongestant and Panadol after an oral administration of two tablets to healthy adults under fasting conditions
Secondary ID [1] 281960 0
NIL
Universal Trial Number (UTN)
Trial acronym
AFT MXPE02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cold and Flu 288382 0
Condition category
Condition code
Other 288726 288726 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug and dose: Paracetamol 1000mg and Phenylephrine 10mg
Dose frequency: single dose
Duration Administration: single dose
Mode Administration: Oral tablet
Wash-out between treatments = 7 days
Intervention code [1] 286527 0
Treatment: Drugs
Comparator / control treatment
Paracetamol 1000mg; Phenylephrine HCL 10mg
Frequency - single dose
Duration - single dose
Mode administration - oral tablet
Control group
Active

Outcomes
Primary outcome [1] 288869 0
Evaluation of Pharmacokinetic paramaters [Cmax, AUC, Tmax, T 1/2] of Phenylephrine hydrochloride
Assessed by measurement of plasma drug concentrations
Timepoint [1] 288869 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] 301203 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] 301203 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.
Primary outcome is derived from the plasma-time AUC values over this entire time period

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, Rx 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
90% confidence intervals for the mean ratios calculated using the residual variance from an ANOVA of log transformed values.
The ANOVA model will include terms for participant, period and formulation.

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] 4870 0
Jordan
State/province [1] 4870 0

Funding & Sponsors
Funding source category [1] 286736 0
Commercial sector/Industry
Name [1] 286736 0
AFT Pharma
Address [1] 286736 0
Level 1, 129 Hurstmere Rd, Takapuna, Auckland, 0622
Country [1] 286736 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharma
Address
Level 1, 129 Hurstmere Rd, Takapuna 0622
Country
New Zealand
Secondary sponsor category [1] 285512 0
None
Name [1] 285512 0
Address [1] 285512 0
Country [1] 285512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288809 0
IPRC Institutional Review Board
Ethics committee address [1] 288809 0
172 Queen Rania St
PO Box 963166
Amman 11942
Ethics committee country [1] 288809 0
Jordan
Date submitted for ethics approval [1] 288809 0
11/02/2013
Approval date [1] 288809 0
24/02/2013
Ethics approval number [1] 288809 0

Summary
Brief summary
To measure the pharmacokinetics [how the body treats drugs] of phenylephrine in humans since this is still not well understood
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37878 0
Prof Abdullah Hiyari
Address 37878 0
International Pharmaceutical Research Center
Queen Rania St - Sport City Circle
PO Box 963166
Amman 11196
Country 37878 0
Jordan
Phone 37878 0
+962562764/51
Fax 37878 0
+96265627654
Email 37878 0
iprc@iprc.com.jo
Contact person for public queries
Name 37879 0
Dr Isam Salem
Address 37879 0
International Pharmaceutical Research Center
Queen Rania St - Sport City Circle
PO Box 963166
Amman 11196
Country 37879 0
Jordan
Phone 37879 0
+962562764/51
Fax 37879 0
+96265627654
Email 37879 0
dr.salem@iprc.com.jo
Contact person for scientific queries
Name 37880 0
Dr Hartley Atkinson
Address 37880 0
Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Country 37880 0
New Zealand
Phone 37880 0
+6494880232
Fax 37880 0
Email 37880 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