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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

Last updated on December 16, 2017

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Study Location
Pfizer Investigational Site
Navi Mumbai, Maharashtra, 400709 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00875030
Pfizer
Completed
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

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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
A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 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).
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy Volunteers
  • Drug: artesunate sachets
    single dose 50 mg (2 X 25 mg) artesunate sachets
  • Drug: Arsuamoon
    single dose 50 mg arsuamoon tablet
  • Experimental: 1.0
    Intervention: Drug: artesunate sachets
  • Active Comparator: 2.0
    Intervention: Drug: Arsuamoon
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00875030
B0551002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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