To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

NCT ID: NCT01112462

Last Updated: 2012-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-06-30

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.

Conditions

Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Tablet

Paracetamol 500 mg/Phenylephrine 5 mg tablet

Group Type: EXPERIMENTAL

Paracetamol 500 mg/Phenylephrine 5 mg tablets

Intervention Type: DRUG

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

Sachet

Paracetamol 1000 mg/Phenylephrine 10 mg sachet

Group Type: ACTIVE_COMPARATOR

Paracetamol 1000 mg/Phenylephrine 10 mg sachet

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Sudafed PE Sinus Pain Relief™; Flu Plus Hot Lemon™ sachet

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McNeil AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

Shandon Clinical Trials Ltd.

Cork, , Ireland

Countries

Ireland

Other Identifiers

2009-018093-55

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SC02009

Identifier Type: -

Identifier Source: org_study_id