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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Malaria

Treatments: Drug: Artesunate + Amodiaquine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00386503

ARAMF_L_01570

Details and patient eligibility

About

• 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™

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)