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Completed

NCT Number: NCT00894374

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

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

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Key information

Conditions

Falciparum Malaria Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artesunate (Test)

Drug

Oral tablet, single dose, 1 x 100 mg

Artesunate (Comparator)

Drug

Oral tablet, single dose, 2 x 50 mg

Primary outcomes

  1. AUC and Cmax of active metabolite of artesunate

    Time frame: 30-Aug-2009

Secondary outcomes

  1. Tolerability

    Time frame: 30-Aug-2009

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 7, 2009
Registry last updated
Jun 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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