NCT02902666

Bioequivalence Study of One Tablet of Paracetamol 1000 mg + Codeine 30 mg vs. Two Tablets of Paracetamol 500 mg + Codeine 30 mg

A Single Dose Bioequivalence Study of Test Product (One Tablet of Paracetamol 1000 mg + Codeine 30 mg, Manufactured by A.C.R.A.F. S.p.A.) vs. Two Tablets of the Reference Product (Paracetamol 500 mg + Codeine 30 mg) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the bioequivalence of a new paracetamol 1000 mg/codeine 30 mg formulation vs. the marketed reference Co-efferalgan® 500 mg/30 mg in terms of rate and extent of absorption, when administered as single oral dose (one tablet of the new A.C.R.A.F. formulation vs. two tablets of the reference formulation Co-efferalgan®) to healthy male and female volunteers, under fasting conditions, in two consecutive study periods.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Paracetamol 1000 mg/codeine phosphate hemihydrate 30 mg tablet
DRUG	Paracetamol 500 mg/codeine phosphate hemihydrate 30 mg tablet

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-09-16
• Last updated: 2016-09-16