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

Falciparum Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894374
• Other study ID #: B0551003
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2009
• Last updated: June 24, 2010
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: June 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Falciparum Malaria
• Malaria, Falciparum

Intervention

Drug:
• Artesunate (Test)
Oral tablet, single dose, 1 x 100 mg
• Artesunate (Comparator)
Oral tablet, single dose, 2 x 50 mg

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC and Cmax of active metabolite of artesunate		30-Aug-2009	No
Secondary	Tolerability		30-Aug-2009	No

External Links

•   To obtain contact information for a study center near you, click here.