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.

Phase 1

Completed

• Conditions: Pain; Nasal Congestion; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12615000740594
• Lead Sponsor: AFT Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified