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

Overview

The primary objective of the study is to determine bioequivalence of 50 mg (2×25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1×50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard for artesunate The secondary objective is to assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).

Full Title of Study: “A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2009

Interventions

  • Drug: artesunate sachets
    • single dose 50 mg (2 X 25 mg) artesunate sachets
  • Drug: Arsuamoon
    • single dose 50 mg arsuamoon tablet

Arms, Groups and Cohorts

  • Experimental: 1.0
  • Active Comparator: 2.0

Clinical Trial Outcome Measures

Primary Measures

  • Cmax, AUCinf and AUClast, for DHA
    • Time Frame: 1 year

Secondary Measures

  • Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate.
    • Time Frame: 1 year
  • Safety laboratory tests, vital signs, and adverse events.
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. – Body Mass Index (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:

  • Any condition possibly affecting drug absorption. – A positive urine drug screen. – Have a known history of hypersensitivity, allergy (except for untreated, asymptomatic, seasonal allergies at the time of dosing), severe adverse drug reaction, or intolerance to artesunate or its derivatives.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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