NCT01112462

To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.

Detailed description

The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females. Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 days. In each study period, sixteen blood samples for pharmacokinetic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of paracetamol and phenylephrine in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	Paracetamol 500 mg/Phenylephrine 5 mg tablets	2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period
DRUG	Paracetamol 1000 mg/Phenylephrine 10 mg sachet	1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-04-28
• Last updated: 2012-07-10

Locations

1 site across 1 country: Ireland