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

Falciparum Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859807
• Other study ID #: B0731001
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2009
• Last updated: April 20, 2010
• Start date: May 2009
• Est. completion date: June 2009

Study information

• Verified date: April 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Falciparum Malaria
• Malaria, Falciparum

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Navi Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax, AUCtlast and AUCinf for amodiaquine.		end of study	No
Secondary	Cmax and AUC72 for DesethylAQ		end of study	No

External Links

•   To obtain contact information for a study center near you, click here.