Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00894660

Falciparum Malaria

COMPLETED PHASE1

A Study Comparing Blood Levels After Single-Dose Administration Of Artesunate Sachets (Pfizer) Versus Single-Dose Administration Of Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

NCT00875030

Healthy Volunteers

COMPLETED PHASE4

Bioequivalence Trial of Pyronaridine Artesunate To-be-marketed Tablet to the Clinical Trial Reference Tablet

NCT00682630

Malaria

COMPLETED PHASE1

Safety and Efficacy Study of IV Artesunate to Treat Malaria

NCT00298610

Malaria

COMPLETED PHASE2

Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

NCT00445796

Malaria

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Falciparum Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Artesunate (Pfizer)

Group Type EXPERIMENTAL

Artesunate (Test)

Intervention Type DRUG

Oral tablet, single dose, 1 x 100 mg

Artesunate (Arsuamoon® Tablets Guilin-China)

Group Type ACTIVE_COMPARATOR

Artesunate (Comparator)

Intervention Type DRUG

Oral tablet, single dose, 2 x 50 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Artesunate (Test)

Oral tablet, single dose, 1 x 100 mg

Intervention Type DRUG

Artesunate (Comparator)

Oral tablet, single dose, 2 x 50 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.