Confirmatory pharmacokinetic study of paracetamol and phenylephrine hydrochloride in healthy adults

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000090617
• Date of registration: 23/01/2014
• Prospective Registration: Yes
• Primary sponsor: AFT Pharmaceuticals Ltd
• 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
• Date of first enrolment: 14/04/2014
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000090617.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 volunteers
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

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

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Cold & Flu;
Cold & Flu

Intervention(s)

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

Primary Outcome(s)

Evaluation of pharmacokinetic paramaters [Cmax, AUC, Tmax, T 1/2] of Phenylephrine hydrochloride
Assessed by measurement of plasma drug concentrations
[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(s)

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.
[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.
]

Secondary ID(s)

NIL

Source(s) of Monetary Support

AFT Pharmaceuticals Ltd

Ethics review

Status: Approved
Approval date:
Contact:

IPRC Institutional Review Board