Bioequivalence of Pyronaridine Artesunate To-be-marketed Tablet to the Clinical Trial Reference Tablet

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medicines for Malaria Venture
• Collaborator: Shin Poong Pharmaceuticals
• Treatments: Artemisinins; Artesunate; Pyronaridine

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