To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112462
• Other study ID #: SC02009
• Secondary ID: 2009-018093-55
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2010
• Last updated: July 6, 2012
• Start date: March 2010
• Est. completion date: June 2010

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Respiratory Tract Infections

Intervention

Drug:
• 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
• Paracetamol 1000 mg/Phenylephrine 10 mg sachet
1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period

Locations

Country	Name	City	State
Ireland	Shandon Clinical Trials Ltd.	Cork

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No