Back to resultsBioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Primary Purpose
Falciparum Malaria
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Artesunate (Test)
Artesunate (Comparator)
Sponsored by
About this trial
This is an interventional basic science trial for Falciparum Malaria focused on measuring Bio-equivalence, Healthy Volunteers
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Artesunate (Pfizer)
Artesunate (Arsuamoon® Tablets Guilin-China)
Arm Description
Outcomes
Primary Outcome Measures
AUC and Cmax of active metabolite of artesunate
Secondary Outcome Measures
Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00894374
Brief Title
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Official Title
A Single-Dose Bioequivalence Study Comparing Artesunate Tablet (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Falciparum Malaria
Keywords
Bio-equivalence, Healthy Volunteers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Artesunate (Pfizer)
Arm Type
Experimental
Arm Title
Artesunate (Arsuamoon® Tablets Guilin-China)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Artesunate (Test)
Intervention Description
Oral tablet, single dose, 1 x 100 mg
Intervention Type
Drug
Intervention Name(s)
Artesunate (Comparator)
Intervention Description
Oral tablet, single dose, 2 x 50 mg
Primary Outcome Measure Information:
Title
AUC and Cmax of active metabolite of artesunate
Time Frame
30-Aug-2009
Secondary Outcome Measure Information:
Title
Tolerability
Time Frame
30-Aug-2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0551003&StudyName=Bioequivalence%20Study%20Comparing%20Artesunate%20Tablet%20To%20Arsuamoon%AE%20Tablets%20%28Guilin-China%29%20In%20Healthy%20Subjects
Description
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Learn more about this trial
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
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