Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions
Overview
– 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™
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2006
Interventions
- Drug: Artesunate + Amodiaquine
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Safety and tolerability/Adverse events, physical examinations, vital signs including heart rate and blood pressure, ECG and laboratory parameters.
- Time Frame: From the signature of the informed consent up to the end of the study
Participating in This Clinical Trial
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.
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Sanofi
- Provider of Information About this Clinical Study
- Medical Affairs Study Director, sanofi-aventis
- Overall Official(s)
- Valerie Lameyre, Study Director, Sanofi
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