A Randomized, Open-Label, Cross-Over Study, to Compare the Bioavailability of the Fixed Combination of Amodiaquine and Artesunate (COARSUCAM™) After Single Oral Administration Under Fed and Fasted Conditions in Healthy Subjects

Sanofi1 site in 1 country22 target enrollmentJune 2006

ConditionsMalaria

DrugsArtesunate + Amodiaquine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Malaria
Sponsor: Sanofi
Enrollment: 22
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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™

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

December 2006

Last Updated

17 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Healthy Caucasian subjects
•Weight between 50 kg and 90 kg. 18 ≤ Body Mass Index ≤ 28 kg/m
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Time Frame: During all the study conduct

Tmax, Cmax, Truncated AUC(0-10d) for DSA

Time Frame: during the study conduct

Secondary Outcomes

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)