Bioequivalence of Pyronaridine Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet (SP-C-009-07)
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ClinicalTrials.gov Identifier: NCT00682630 |
Recruitment Status
:
Completed
First Posted
: May 22, 2008
Last Update Posted
: January 22, 2009
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Sponsor:
Medicines for Malaria Venture
Collaborator:
Shin Poong Pharmaceuticals
Information provided by:
Medicines for Malaria Venture
Tracking Information | |||
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First Submitted Date ICMJE | May 19, 2008 | ||
First Posted Date ICMJE | May 22, 2008 | ||
Last Update Posted Date | January 22, 2009 | ||
Study Start Date ICMJE | September 2007 | ||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
To determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose of 720:240 mg in healthy adults. [ Time Frame: 85 days ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT00682630 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
To assess the safety of the two formulations in relation to one another [ Time Frame: 85 days ] | ||
Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Bioequivalence of Pyronaridine Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet | ||
Official Title ICMJE | Bioequivalence Trial of Pyronaridine:Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet | ||
Brief Summary | The objective of the study is to determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose of 720:240 mg in healthy adults. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 1 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Malaria | ||
Intervention ICMJE | Drug: pyronaridine artesunate
720:240 mg of the reference tablet formulation; wash out period of 43 days; 720:240 mg of the to-be-marketed formulation; wash out period of 43 days |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Estimated Enrollment ICMJE |
42 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Actual Study Completion Date | September 2008 | ||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 45 Years (Adult) | ||
Accepts Healthy Volunteers | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Switzerland | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00682630 | ||
Other Study ID Numbers ICMJE | SP-C-009-07 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Medical Director, Medicines for Malaria Venture | ||
Study Sponsor ICMJE | Medicines for Malaria Venture | ||
Collaborators ICMJE | Shin Poong Pharmaceuticals | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Medicines for Malaria Venture | ||
Verification Date | January 2009 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |