Relative Bioavailability of Pyronaridine-artesunate in Tablet and Granule Formulations, in Healthy Volunteers
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pyronaridine-artesunate granules (Period 1) In first dosing period, single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate. In second dosing period, cross-over to single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate. |
Drug: pyronaridine-artesunate granules
Other Names:
Drug: Pyronaridine-artesunate tablets
Other Names:
|
| Active Comparator: Pyronaridine-artesunate tablets (Period1) In first dosing period, single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate. In second dosing period, cross-over to single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate. |
Drug: pyronaridine-artesunate granules
Other Names:
Drug: Pyronaridine-artesunate tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Area Under the concentration-time Curve from hour 0 to the last sampling point (AUC 0-t) for pyronaridine and dihydroartemisinin (DHA) [Pyronaridine PK to Day 43; DHA PK to 24 hours post dose.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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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;
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An informed consent document signed and dated by the subject (prior to screening and any study activities, including discontinuation of any prohibited medications)
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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.
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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)]
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Female subjects of childbearing potential with a negative urine pregnancy test at screening, and a negative pregnancy blood test on admission, and who :
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agree to double barrier method of contraception for 4 weeks before first study drug administration and throughout the entire study follow up period, or
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whose partner has undergone vasectomy and has been negative for sperm for at least 6 months
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Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
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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)
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Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins
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Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
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Seropositive HIV antibody, seropositive syphilis [Syphilis reagin test (+)]
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Previous exposure to pyronaridine-artesunate (Pyramax)
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Present or recent history (last two years) of tobacco abuse (≥10 cigarettes/day)
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Known or suspected alcohol abuse or illicit drug use up to 5 years before the study start or positive findings on urine drug screen
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Intake of alcoholic beverages or caffeine-containing food or beverages, such as coffee, tea, chocolate, or cola, 48 hours before study drug administration
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Intake of grapefruit, Seville oranges or products containing these from 72 hours before the start of study drug administration
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Gilbert's disease
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Use of over-the-counter (OTC) medications, including vitamins, analgesics, antipyretics or antacids within 7 days before study drug administration
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Use of prescription medications within 14 days before the start of study drug administration or required chronic use of any prescription medication
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Use of enzyme-altering agents (e.g. barbiturates, phenothiazines, cimetidine, etc.) within 30 days before the start of study drug administration
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Plasma donation within 60 days before the start of study drug administration
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Blood donation of 500 mL or more within 60 days before the start of study drug administration
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Participation AND having had drug administration in any other clinical study within the 60 days before start of study drug administration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept. of Clinical Pharmacology and Therapeutics, Asan Medical Center, Univ. of Ulsan | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Medicines for Malaria Venture
- Shin Poong Pharmaceutical Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SP-C-017-12