Bioequivalence of Pyronaridine Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet (SP-C-009-07)

Tracking Information
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; (submitted: May 21, 2008)	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; (submitted: May 21, 2008)	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
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
Study Arms	Experimental: Study Group 1 Study Period 1: Treatment A (clinical trial reference tablets) 43 Days wash out Study Period 2: Treatment B (to-be-marketed tablets) 43 Days follow-up Intervention: Drug: pyronaridine artesunate; Experimental: Study Group 2 Study Period 1: Treatment B (to-be-marketed tablets) 43 Days wash out Study Period 2: Treatment A (clinical trial reference tablets). 43 Days follow-up Intervention: Drug: pyronaridine artesunate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: May 21, 2008)	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: Male or female subjects between the ages of 18 and 45 years with a body weight between 55 and 75 kg and a body mass index using Quetelet's Index - weight (kg)/height2 (m2) between 18-28; Signed and dated a written informed consent form before undergoing any study related activities, including discontinuation of any prohibited medications; Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical investigator; Normal (or abnormal and clinically insignificant) laboratory values at screening Exclusion Criteria: Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute QTc interval greater or equal to 450 mseconds), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma); Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins
Sex/Gender	Sexes Eligible for Study: All
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