- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00859807
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
April 20, 2010 updated by: Pfizer
The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer) and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maharashtra
-
Navi Mumbai, Maharashtra, India, 400709
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs).
- An informed consent document signed and dated by the subject or a legally acceptable representative.
Exclusion Criteria:
- A history of drug induced agranulocytosis and history of liver and hematological problems while taking amodiaquine.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence 1 (19 subjects)
Period 1: treatment A (15.3 mL (50 mg/5 mL) AQ suspension (Pfizer); test treatment. Period 2: treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis); reference treatment). |
Treatment A 15.3 mL (50 mg/5 mL) AQ suspension single dose.
Treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis) single dose.
Other Names:
|
Experimental: Sequence 2 (19 subjects)
Period 1: treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis Period 2: treatment A (15.3 mL (50 mg/5 mL) AQ suspension (Pfizer); test treatment
|
Treatment A 15.3 mL (50 mg/5 mL) AQ suspension single dose.
Treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis) single dose.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax, AUCtlast and AUCinf for amodiaquine.
Time Frame: end of study
|
end of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax and AUC72 for DesethylAQ
Time Frame: end of study
|
end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
March 6, 2009
First Submitted That Met QC Criteria
March 10, 2009
First Posted (Estimate)
March 11, 2009
Study Record Updates
Last Update Posted (Estimate)
April 21, 2010
Last Update Submitted That Met QC Criteria
April 20, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B0731001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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