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.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000740594
• Date of registration: 17/07/2015
• Prospective Registration: Yes
• Primary sponsor: AFT Pharmaceuticals Ltd.
• 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.
• Date of first enrolment: 01/09/2015
• Target sample size: 12
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000740594.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Pharmacokinetics;
• Phase: Phase 1

Countries of recruitment

Jordan

Contacts

• Name: Dr Hartley Atkinson

• Name: Dr Hartley Atkinson

Key inclusion & exclusion criteria

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.

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.

Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Pain ;Nasal Congestion;
Pain
Nasal Congestion

Respiratory - Other respiratory disorders / diseases

Intervention(s)

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.

Primary Outcome(s)

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.[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(s)

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.[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.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

AFT Pharmaceuticals Ltd.

Ethics review

Status: Approved
Approval date:
Contact:

International Pharmaceuticals Research Centre