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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* 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™

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Artesunate + Amodiaquine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

sanofi-aventis

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valerie Lameyre

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanofi-Aventis

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ARAMF_L_01570

Identifier Type: -

Identifier Source: org_study_id