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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Falciparum Malaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Amodiaquine (Pfizer)

Group Type EXPERIMENTAL

Amodiaquine (Test)

Intervention Type DRUG

Oral tablet, single dose, 1 X 300 MG

Amodiaquine tablets (Arsuamoon-Guilin China)

Group Type ACTIVE_COMPARATOR

Amodiaquine (Comparator)

Intervention Type DRUG

Oral tablet, single dose, 2 X 150 MG

Interventions

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Amodiaquine (Test)

Oral tablet, single dose, 1 X 300 MG

Intervention Type DRUG

Amodiaquine (Comparator)

Oral tablet, single dose, 2 X 150 MG

Intervention Type DRUG

Other Intervention Names

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Camoquin Camoquin

Eligibility Criteria

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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.