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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00894374
Other study ID # B0551003
Secondary ID
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


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
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