Phase I, Randomized, Single Dose, Bioequivalence Trial of Pyronaridine Artesunate To-be-marketed Tablet to the Clinical Trial Reference Tablet

SP-C-009-07

The primary objective of this 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. The secondary objective is to assess the safety of the two formulations.

2007-09-01

2008-07-01

2008-09-01

Completed

Early phase I

42

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 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 5. Female subjects of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who was post-menopausal (i.e., one year without menses) 6. Female subjects of childbearing potential with a negative urine pregnancy test at screening and who agreed to one of the accepted forms of contraception 7. The ability to understand the requirements of the study and willingness to comply with all study procedures 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 3. Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab) 4. Known seropositive HIV antibody 5. Previous participation in any clinical trial with pyronaridine artesunate 6. Presence or recent history (last two years) of tobacco abuse (≥10 cigarettes/day) 7. Known or suspected alcohol abuse or illicit drug use 10 years before the study start or positive findings on urine drug screen 8. Intake of alcoholic beverages or caffeine-containing food or beverages, such as coffee, tea, chocolate, or cola, 24 h before study drug administration 9. Use of over-the-counter (OTC) medications, including vitamins, analgesics, or antacids, 72 h before the study start 10. Use of prescription medications 14 days before the study start or required chronic use of any prescription medication 11. Use of enzyme-altering agents (e.g., barbiturates, phenothiazines, cimetidine, etc.) 30 days before the study start 12. Plasma donation 3 months before the study start 13. Blood donation of 500 mL or more 3 months before the study start 14. Participation in an investigational drug study 3 months before randomization

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}

2023-02-03