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

Pfizer38 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Falciparum Malaria

Interventions

Amodiaquine (Test)DRUG

Oral tablet, single dose, 1 X 300 MG

Amodiaquine (Comparator)DRUG

Oral tablet, single dose, 2 X 150 MG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Singapore, Singapore, Singapore

Outcomes

Primary Outcomes

AUC and Cmax of amodiaquine

Time frame: 1 month

Secondary Outcomes

Tolerability

Time frame: 1 month

Data from ClinicalTrials.gov

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