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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00386503

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jun 1, 2006

Actual Primary Completion Date :

Dec 1, 2006

Outcome Measures

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 [During all the study conduct]
Tmax, Cmax, Truncated AUC(0-10d) for DSA [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. [From the signature of the informed consent up to the end of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

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

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Paris		France

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Valerie Lameyre, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00386503

Other Study ID Numbers:

ARAMF_L_01570

First Posted:

Oct 11, 2006

Last Update Posted:

Dec 9, 2008

Last Verified:

Dec 1, 2008

Additional relevant MeSH terms:

Malaria

Artesunate

Amodiaquine

Study Results

No Results Posted as of Dec 9, 2008