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

Purpose

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

Condition	Intervention	Phase
Falciparum Malaria	Drug: Flavoquine®, Camoquin® Suspension	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Malaria

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Cmax, AUCtlast and AUCinf for amodiaquine. [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cmax and AUC72 for DesethylAQ [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	May 2009
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sequence 1 (19 subjects) 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).	Drug: Flavoquine®, 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. Other Name: amodiaquine
Experimental: Sequence 2 (19 subjects) 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	Drug: Flavoquine®, 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. Other Name: amodiaquine

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859807

Locations

India
Pfizer Investigational Site
Navi Mumbai, Maharashtra, India, 400709

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00859807 History of Changes
Other Study ID Numbers:	B0731001
Study First Received:	March 6, 2009
Last Updated:	April 20, 2010
Health Authority:	India: Institutional Review Board

Keywords provided by Pfizer:

Amodiaquine suspension
Flavoquine tablets
Bioequivalence study

Additional relevant MeSH terms:

Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Amodiaquine
Antimalarials

Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013