To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

Phase 1

Completed

• Conditions: Respiratory Tract Infections
• Interventions: Drug: Paracetamol 500 mg/Phenylephrine 5 mg tablets; Drug: Paracetamol 1000 mg/Phenylephrine 10 mg sachet

• Registration Number: NCT01112462
• Lead Sponsor: McNeil AB

Brief 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy male and female
• Caucasians
• Aged between 18 and 50 years
• BMI ≤ 30 kg/m2
• Clinically normal medical history
• Physical normal examination
• Normal laboratory test results

Exclusion Criteria

• Pregnancy, lactation or intended pregnancy
• Hypersensitivity to or intolerant of the study medications
• Donation or loss of blood within 90 days preceding the first dose of study medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tablet	Paracetamol 500 mg/Phenylephrine 5 mg tablets	Paracetamol 500 mg/Phenylephrine 5 mg tablet
Sachet	Paracetamol 1000 mg/Phenylephrine 10 mg sachet	Paracetamol 1000 mg/Phenylephrine 10 mg sachet

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic measurements	during 24 hours following drug administration	Pharmacokinetic measurements including: * Cmax (Maximum concentration); * AUC0-t (Area under the plasma concentration versus time curve from 0h to the lastmeasurable concentration); * AUC0-inf (Area under the plasma concentration versus time curve from 0h to infinity)

Trial Locations

Locations (1)

Shandon Clinical Trials Ltd.; 🇮🇪 Cork, Ireland