Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions

Phase 1

Completed

• Conditions: Malaria

• Registration Number: NCT00386503
• Lead Sponsor: Sanofi

Brief Summary

* Primary Objective: to evaluate the interaction with food after a single oral dose of a fixed combination of amodiaquine (AQ) and artesunate (AS) (COARSUCAM™) in healthy male subjects

* Secondary Objective: to assess the clinical and biological safety and tolerability of Coarsucam™

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Primary Completion: 2006-12
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-08
• Last Update Posted: 2008-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

• Healthy Caucasian subjects
• Weight between 50 kg and 90 kg. 18 ≤ Body Mass Index ≤ 28 kg/m2.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics/Time course of the plasma concentrations of AS, AQ & their pharmacologically active metabolites dihydroartemisinin (DHA) & desethylamodiaquine (DSA), used to determine:Tmax, Cmax, t1/2, AUC(0-t) & AUC(0-Inf) for AS, DHA & AQ	During all the study conduct
Tmax, Cmax, Truncated AUC(0-10d) for DSA	during the study conduct

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability/Adverse events, physical examinations, vital signs including heart rate and blood pressure, ECG and laboratory parameters.	From the signature of the informed consent up to the end of the study

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Paris, France