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

Pfizer logo

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)

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
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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