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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