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Trial registered on ANZCTR


Registration number
ACTRN12615000740594
Ethics application status
Approved
Date submitted
7/07/2015
Date registered
17/07/2015
Date last updated
22/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to evaluate and compare the pharmacokinetic parameters of different doses of phenylephrine hydrochloride combined with paracetamol in 12 healthy adults under fasting conditions.
Scientific title
Comparative, randomized, single-dose, five period, cross-over open label, pilot study to evaluate the pharmacokinetic parameters of different doses of phenylephrine hydrochloride combined with paracetamol in 12 healthy adults under fasting conditions.
Secondary ID [1] 287054 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 295536 0
Nasal Congestion 295579 0
Condition category
Condition code
Respiratory 295814 295814 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 healthy participants will be randomly allocated, in a five-way cross-over manner, to the following treatments:
Treatment A: 650 mg paracetamol and 5 mg phenylephrine hydrochloride
Treatment B: 650 mg paracetamol and 5.2 mg phenylephrine hydrochloride
Treatment C: 650 mg paracetamol and 5.4 mg phenylephrine hydrochloride
Treatment D: 650 mg paracetamol and 5.6 mg phenylephrine hydrochloride).
Treatment E: 650 mg paracetamol and 5.8 mg phenylephrine hydrochloride
Each of the treatment will be administered orally, as a single dose. The administration of the study drugs is done under the supervision of the study staff.
There will be a washout period of 7 days between each of the study treatments
Participants will be required to fast overnight (for at least 10 hours) before dosing and for 4 hours thereafter.
Intervention code [1] 292282 0
Treatment: Drugs
Comparator / control treatment
Treatment A: 650 mg paracetamol and 5 mg phenylephrine hydrochloride
Control group
Dose comparison

Outcomes
Primary outcome [1] 295507 0
To determine and compare the pharmacokinetic parameters (Cmax, AUCt, AUCinf, Tmax) of different doses of phenylephrine hydrochloride (5-5.8 mg) when taken in combination with 650 mg paracetamol.
Timepoint [1] 295507 0
Plasma time concentrations will be determined from the blood samples collected at 5, 15, 30, 45 minutes and 1.00, 1.25, 1.50, 2.00, 3.00, 6.00, 8.00, 10.00 and 12.00 hours after each study drug administration.
Secondary outcome [1] 315723 0
To monitor the safety and tolerability of the different doses of phenylephrine hydrochloride (5-5.8 mg) when combined with 650 mg of paracetamol. This is a composite secondary outcome.

Safety will be assessed by assessing the frequency and percentage of adverse events.Changes from baseline (prior to dosing) of blood pressure and heart rate results will be compared between the treatment groups.
Timepoint [1] 315723 0
Safety will be evaluated during each study period and throughout the whole duration of the study
Vital signs will be measured pre-dosing and at 15, 30 minutes and at 1.00, 1.50, 2.00, 2.5, 3.0, 4.00, 8.00 and 12.00 hours after study drug administration.

Eligibility
Key inclusion criteria
Healthy subjects, males and females aged 18 to 40 years of age. Females must be infertile or using adequate contraception. Participants must not have taken any prescription medications for at least 14 days or over-the-counter medications for at least 3 days before the start of each study phase, with the exception of oral contraceptives and the study medication.
All subjects must be deemed healthy on the basis of a medical history, physical exam, urinalysis, and blood biochemical and haematological examinations.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Women who are pregnant or nursing
- Women of childbearing potential who are unwilling to take adequate contraceptive precautions
- Women of childbearing potential who are unwilling to undergo a urine pregnancy test
- Have any history of allergy or hypersensitivity to paracetamol and phenylephrine hydrochloride
- Have a history of drug abuse or positive test results for drug abuse during screening.
- Be able and willing to abstain from all prescription and over-the-counter medications (excluding the study drug and oral contraceptive) and herbal remedies for the duration of the study.

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)
Randomization will occur once participant eligibility is confirmed. Participants will be randomly assigned to one of the five possible study drug treatment sequences in a fashion that ensures: that each individual receives each treatment, that for each study period at least 12 participants are allocated to each treatment and that first-order carry-over effects are minimized. Each successive participant will receive a unique study identification number.
Allocation is done by contacting the holder of the allocation schedule who is located at the central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization sequences
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
Pharmacokinetic parameters will be summarized using standard descriptive statistics, including means, medians, geometric means, ranges, inter-quartile ranges, standard deviations and standard errors.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2015
Actual
1/09/2015
Date of last participant enrolment
Anticipated
2/11/2015
Actual
3/10/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 7025 0
Jordan
State/province [1] 7025 0

Funding & Sponsors
Funding source category [1] 291612 0
Commercial sector/Industry
Name [1] 291612 0
AFT Pharmaceuticals Ltd.
Country [1] 291612 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals Ltd.
Address
Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland
Country
New Zealand
Secondary sponsor category [1] 290283 0
None
Name [1] 290283 0
Address [1] 290283 0
Country [1] 290283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293146 0
International Pharmaceuticals Research Centre
Ethics committee address [1] 293146 0
1 Queen Rania Street
Sport City Circle
Amman 1196
Jordan
Ethics committee country [1] 293146 0
Jordan
Date submitted for ethics approval [1] 293146 0
20/07/2015
Approval date [1] 293146 0
01/08/2015
Ethics approval number [1] 293146 0

Summary
Brief summary
This is a Phase I pilot study designed to evaluate the pharmacokinetic profile of fixed dose combinations of paracetamol 325 mg, and phenylephrine hydrochloride at doses between 2.5 and 2.9 mg per tablet, when given as two tablets per dose. The results of this study will guide the selection of the further dose strength of phenylephrine hydrochloride to be used in a fixed dose combination with paracetamol 325 mg, which will be further evaluated in a larger confirmatory pharmacokinetic study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58654 0
Dr Abdullah Hiyari
Address 58654 0
International Pharmaceutical Research Centre
1 Queen Rania Street
Sport City Circle
Amman 1196
Jordan
Country 58654 0
Jordan
Phone 58654 0
+962-6-5627648
Fax 58654 0
Email 58654 0
[email protected]
Contact person for public queries
Name 58655 0
Hartley Atkinson
Address 58655 0
AFT Pharmaceuticals Ltd. - Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland
Country 58655 0
New Zealand
Phone 58655 0
+64 9 488 0232
Fax 58655 0
Email 58655 0
[email protected]
Contact person for scientific queries
Name 58656 0
Hartley Atkinson
Address 58656 0
AFT Pharmaceuticals Ltd. - Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland
Country 58656 0
New Zealand
Phone 58656 0
+64 9 488 0232
Fax 58656 0
Email 58656 0
[email protected]

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
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Documents added automatically
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