A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
Phase 4
Completed
- Conditions
- Falciparum Malaria
- Interventions
- Drug: Flavoquine®, Camoquin® Suspension
- Registration Number
- NCT00859807
- Lead Sponsor
- Pfizer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 (19 subjects) Flavoquine®, Camoquin® Suspension 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). Sequence 2 (19 subjects) Flavoquine®, Camoquin® Suspension 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
- Primary Outcome Measures
Name Time Method Cmax, AUCtlast and AUCinf for amodiaquine. end of study
- Secondary Outcome Measures
Name Time Method Cmax and AUC72 for DesethylAQ end of study
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇮🇳Navi Mumbai, Maharashtra, India