Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

A Single-Dose Bioequivalence Study Comparing Artesunate Tablet (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00894374

Enrollment

Registered

2009-05-07

Start date

2009-06-30

Completion date

2009-08-31

Last updated

2010-06-25

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

Conditions

Falciparum Malaria

Keywords

Bio-equivalence, Healthy Volunteers

Brief summary

The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).

Interventions

DRUGArtesunate (Test)

Oral tablet, single dose, 1 x 100 mg

DRUGArtesunate (Comparator)

Oral tablet, single dose, 2 x 50 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 active metabolite of artesunate	30-Aug-2009

Secondary

Measure	Time frame
Tolerability	30-Aug-2009

Countries

Singapore

Outcome results

None listed

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