A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 4

Conditions: Falciparum Malaria

Treatments: Drug: Flavoquine®, Camoquin® Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00859807

B0731001

Details and patient eligibility

About

The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer) and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).

Enrollment: 38 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Sequence 1 (19 subjects)

Experimental group

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).

Treatment:

Drug: Flavoquine®, Camoquin® Suspension

Drug: Flavoquine®, Camoquin® Suspension

Sequence 2 (19 subjects)

Experimental group

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

Treatment:

Drug: Flavoquine®, Camoquin® Suspension

Drug: Flavoquine®, Camoquin® Suspension