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

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ClinicalTrials.gov Identifier: NCT00386503
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : December 9, 2008
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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™

Condition or disease Intervention/treatment Phase
Malaria Drug: Artesunate + Amodiaquine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : June 2006
Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 ]
  2. Tmax, Cmax, Truncated AUC(0-10d) for DSA [ Time Frame: during the study conduct ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386503

Paris, France
Sponsors and Collaborators
Study Director: Valerie Lameyre Sanofi

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00386503     History of Changes
Other Study ID Numbers: ARAMF_L_01570
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: December 9, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents