To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

Study Overview
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Brief Summary
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This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.

Detailed Description
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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.

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

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Drug: Paracetamol 500 mg/Phenylephrine 5 mg tablets
* Drug: Paracetamol 1000 mg/Phenylephrine 10 mg sachet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tablet<br>Paracetamol 500 mg/Phenylephrine 5 mg tablet | Drug: Paracetamol 500 mg/Phenylephrine 5 mg tablets<br>* 2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period<br>* Other names: Sudafed PE Sinus Pain Relief™;|
| Active Comparator: Sachet<br>Paracetamol 1000 mg/Phenylephrine 10 mg sachet | Drug: Paracetamol 1000 mg/Phenylephrine 10 mg sachet<br>* 1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period<br>* Other names: Flu Plus Hot Lemon™ sachet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | during 24 hours following drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal congestion, Headache