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
  Purpose

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.


Condition Intervention Phase
Malaria
Drug: pyronaridine artesunate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalence Trial of Pyronaridine:Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet

Resource links provided by NLM:


Further study details as provided by Medicines for Malaria Venture:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To assess the safety of the two formulations in relation to one another [ Time Frame: 85 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 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
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682630

Locations
Switzerland
Cross Research S.A., Phase I Unit
Arzo, Switzerland, 6864
Sponsors and Collaborators
Medicines for Malaria Venture
Shin Poong Pharmaceuticals
  More Information

No publications provided

Responsible Party: Medical Director, Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT00682630     History of Changes
Other Study ID Numbers: SP-C-009-07
Study First Received: May 19, 2008
Last Updated: January 21, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by Medicines for Malaria Venture:
Malaria
anti-malarial
pyronaridine
ACT

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections
Artesunate
Pyronaridine
Amebicides
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014