Back to resultsBioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions
Primary Purpose
Malaria
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Artesunate + Amodiaquine
Sponsored by
About this trial
This is an interventional treatment trial for Malaria
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
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
Tmax, Cmax, Truncated AUC(0-10d) for DSA
Secondary Outcome Measures
Safety and tolerability/Adverse events, physical examinations, vital signs including heart rate and blood pressure, ECG and laboratory parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00386503
Brief Title
Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions
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 Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. 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™
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Artesunate + Amodiaquine
Primary Outcome Measure Information:
Title
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
Title
Tmax, Cmax, Truncated AUC(0-10d) for DSA
Time Frame
during the study conduct
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Lameyre
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions
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