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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00894660

Enrollment

Registered

2009-05-07

Start date

2009-06-30

Completion date

2009-07-31

Last updated

2010-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falciparum Malaria

Keywords

Bioequivalence, Healthy Volunteers

Brief summary

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

Interventions

DRUGAmodiaquine (Test)

Oral tablet, single dose, 1 X 300 MG

DRUGAmodiaquine (Comparator)

Oral tablet, single dose, 2 X 150 MG

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
AUC and Cmax of amodiaquine	1 month

Secondary

Measure	Time frame
Tolerability	1 month

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026