Relative Bioavailability of Pyronaridine-artesunate in Tablet and Granule Formulations, in Healthy Volunteers
Relative Bioavailability of Pyronaridine-artesunate in Tablet and Granule Formulations, in Healthy Volunteers
The purpose of this study is to compare the bioavailability of two formulations (tablets and
 granules for dispersion) of the antimalarial drug Pyramax (which is a combination of
 pyronaridine and artesunate).
Inclusion Criteria:

 -  Healthy male and/or female subjects between the ages of 20 and 45 years, inclusive.
 (Healthy is defined as no clinically relevant abnormalities identified by a detailed
 medical history, full physical examination, including blood pressure and pulse rate
 measurement, 12-lead ECG and clinical laboratory tests)

 -  Weight between 50 kg and 80 kg and Body Mass Index (BMI) calculated using Quetelet's
 Index - weight(kg)/height (m2) between 18.5 to 27 kg/m2;

 -  An informed consent document signed and dated by the subject (prior to screening and
 any study activities, including discontinuation of any prohibited medications)

 -  Strictly normal values of alanine aminotransferase(ALT), aspartate aminotransferase
 (AST), and bilirubin, and normal or abnormal but clinically insignificant results of
 the other blood and urine laboratory parameters at screening.

 -  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) or who has undergone sterilization (via hysterectomy or bilateral
 tubal ligation)]

 -  Female subjects of childbearing potential with a negative urine pregnancy test at
 screening, and a negative pregnancy blood test on admission, and who :

 -  agree to double barrier method of contraception for 4 weeks before first study
 drug administration and throughout the entire study follow up period, or

 -  whose partner has undergone vasectomy and has been negative for sperm for at
 least 6 months

 -  Subjects who are willing and able to comply with scheduled visits, treatment plan,
 laboratory tests, and other study procedures.

 Exclusion Criteria:

 -  Known history or evidence of clinically significant disorders such as cardiovascular
 (including arrhythmia, acute corrected QT interval (QTc) greater or equal to 450
 milliseconds), 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

 -  Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or
 Hepatitis C antibody (HCV Ab)

 -  Seropositive HIV antibody, seropositive syphilis [Syphilis reagin test (+)]

 -  Previous exposure to pyronaridine-artesunate (Pyramax)

 -  Present or recent history (last two years) of tobacco abuse (≥10 cigarettes/day)

 -  Known or suspected alcohol abuse or illicit drug use up to 5 years before the study
 start or positive findings on urine drug screen

 -  Intake of alcoholic beverages or caffeine-containing food or beverages, such as
 coffee, tea, chocolate, or cola, 48 hours before study drug administration

 -  Intake of grapefruit, Seville oranges or products containing these from 72 hours
 before the start of study drug administration

 -  Gilbert's disease

 -  Use of over-the-counter (OTC) medications, including vitamins, analgesics,
 antipyretics or antacids within 7 days before study drug administration

 -  Use of prescription medications within 14 days before the start of study drug
 administration or required chronic use of any prescription medication

 -  Use of enzyme-altering agents (e.g. barbiturates, phenothiazines, cimetidine, etc.)
 within 30 days before the start of study drug administration

 -  Plasma donation within 60 days before the start of study drug administration

 -  Blood donation of 500 mL or more within 60 days before the start of study drug
 administration

 -  Participation AND having had drug administration in any other clinical study within
 the 60 days before start of study drug administration