This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: October 10, 2006
Last updated: December 8, 2008
Last verified: December 2008
  • 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 Intervention Phase
Malaria Drug: Artesunate + Amodiaquine Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome 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 Outcome 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 ]

Estimated Enrollment: 22
Study Start Date: June 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00386503

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

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00386503     History of Changes
Other Study ID Numbers: ARAMF_L_01570
Study First Received: October 10, 2006
Last Updated: December 8, 2008

Additional relevant MeSH terms:
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials processed this record on September 21, 2017