To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

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

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.

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