Back to resultsA Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
Primary Purpose
Falciparum Malaria
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Flavoquine®, Camoquin® Suspension
Flavoquine®, Camoquin® Suspension
Sponsored by
About this trial
This is an interventional treatment trial for Falciparum Malaria focused on measuring Amodiaquine suspension, Flavoquine tablets, Bioequivalence study
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence 1 (19 subjects)
Sequence 2 (19 subjects)
Arm Description
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).
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
Outcomes
Primary Outcome Measures
Cmax, AUCtlast and AUCinf for amodiaquine.
Secondary Outcome Measures
Cmax and AUC72 for DesethylAQ
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00859807
Brief Title
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
Official Title
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer) and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Falciparum Malaria
Keywords
Amodiaquine suspension, Flavoquine tablets, Bioequivalence study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1 (19 subjects)
Arm Type
Experimental
Arm Description
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).
Arm Title
Sequence 2 (19 subjects)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Flavoquine®, Camoquin® Suspension
Other Intervention Name(s)
amodiaquine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Flavoquine®, Camoquin® Suspension
Other Intervention Name(s)
amodiaquine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cmax, AUCtlast and AUCinf for amodiaquine.
Time Frame
end of study
Secondary Outcome Measure Information:
Title
Cmax and AUC72 for DesethylAQ
Time Frame
end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Navi Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400709
Country
India
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0731001&StudyName=A%20Bioequivalence%20Study%20Comparing%20Camoquin%AE%20Suspension%20%28Pfizer%29%20To%20Flavoquine%AE%20Tablets%20%28Sanofi%20Aventis%29%20In%20Healthy%20Subjects%0A%0A
Description
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A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
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