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

NCT00894374 | Completed Phase 1

• 1 other identifier: B0551003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Falciparum Malaria

Keywords

Bio-equivalence, Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• AUC and Cmax of active metabolite of artesunate

  30-Aug-2009

Secondary Outcomes (1)

• Tolerability

  30-Aug-2009

Study Arms (2)

Artesunate (Pfizer)

EXPERIMENTAL

Drug: Artesunate (Test)

Artesunate (Arsuamoon® Tablets Guilin-China)

ACTIVE COMPARATOR

Drug: Artesunate (Comparator)

Interventions

Artesunate (Test) DRUG

Oral tablet, single dose, 1 x 100 mg

Artesunate (Pfizer)

Artesunate (Comparator) DRUG

Oral tablet, single dose, 2 x 50 mg

Artesunate (Arsuamoon® Tablets Guilin-China)

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Evidence or history of clinically significant abnormalities.
• A positive urine drug screen, history of regular alcohol consumption.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Singapore, Singapore, 188770, Singapore

Location

Related Links

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

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Artesunate

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 7, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 25, 2010

Record last verified: 2010-06

Locations

SG (1)