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

This study has been completed.
Sponsor:
Collaborator:
Shin Poong Pharmaceuticals
Information provided by:
Medicines for Malaria Venture
ClinicalTrials.gov Identifier:
NCT00682630
First received: May 19, 2008
Last updated: January 21, 2009
Last verified: January 2009

May 19, 2008
January 21, 2009
September 2007
July 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00682630 on ClinicalTrials.gov Archive Site
To assess the safety of the two formulations in relation to one another [ Time Frame: 85 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Bioequivalence of Pyronaridine Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet
Bioequivalence Trial of Pyronaridine:Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
September 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. Signed and dated a written informed consent form before undergoing any study related activities, including discontinuation of any prohibited medications
  3. Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical investigator
  4. Normal (or abnormal and clinically insignificant) laboratory values at screening

Exclusion Criteria:

  1. 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)
  2. Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00682630
SP-C-009-07
Yes
Medical Director, Medicines for Malaria Venture
Medicines for Malaria Venture
Shin Poong Pharmaceuticals
Not Provided
Medicines for Malaria Venture
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP