To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

McNeil AB40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Respiratory Tract Infections

Interventions

Paracetamol 500 mg/Phenylephrine 5 mg tabletsDRUG

2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period

Paracetamol 1000 mg/Phenylephrine 10 mg sachetDRUG

1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Shandon Clinical Trials Ltd.

Cork, Ireland

Outcomes

Primary Outcomes

Pharmacokinetic measurements

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)

Time frame: during 24 hours following drug administration

Data from ClinicalTrials.gov

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