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

Sanofi22 enrolled

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™

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malaria

Interventions

Artesunate + AmodiaquineDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Paris, France

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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