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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00859807
Other study ID # B0731001
Secondary ID
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


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
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