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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386503
• Other study ID #: ARAMF_L_01570
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2006
• Last updated: December 8, 2008
• Start date: June 2006

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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™

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Artesunate + Amodiaquine

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		During all the study conduct	No
Primary	Tmax, Cmax, Truncated AUC(0-10d) for DSA		during the study conduct	No
Secondary	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	No