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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00859807

Enrollment

Registered

2009-03-11

Start date

2009-05-31

Completion date

2009-06-30

Last updated

2010-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falciparum Malaria

Keywords

Amodiaquine suspension, Flavoquine tablets, Bioequivalence study

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).

Interventions

DRUGFlavoquine®, Camoquin® Suspension

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Cmax, AUCtlast and AUCinf for amodiaquine.	end of study

Secondary

Measure	Time frame
Cmax and AUC72 for DesethylAQ	end of study

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026