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OpenTrials
Completed

NCT Number: NCT00386503

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

* 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™

Completed

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis

Paris, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artesunate + Amodiaquine

Drug

Primary outcomes

  1. 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

  2. Tmax, Cmax, Truncated AUC(0-10d) for DSA

    Time frame: during the study conduct

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
First posted
Oct 11, 2006
Registry last updated
Dec 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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