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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Falciparum Malaria

Treatments: Drug: Amodiaquine (Comparator); Drug: Amodiaquine (Test)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00894660

B0731004

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Amodiaquine (Pfizer)

Experimental group

Treatment:

Drug: Amodiaquine (Test)

Amodiaquine tablets (Arsuamoon-Guilin China)

Active Comparator group

Treatment:

Drug: Amodiaquine (Comparator)