A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Amodiaquine

Criteria

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.

• 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:

• Evidence or history of clinically significant abnormalities.

• A positive urine drug screen, history of regular alcohol consumption.