Status:
COMPLETED
Relative Bioavailability of Pyronaridine-artesunate in Tablet and Granule Formulations in Healthy Volunteers
Lead Sponsor:
Medicines for Malaria Venture
Collaborating Sponsors:
Shin Poong Pharmaceutical Co. Ltd.
Conditions:
Malaria
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to compare the bioavailability of two formulations (tablets and granules for dispersion) of the antimalarial drug pyronaridine-artesunate \[3:1\] (Pyramax, PA) i...
Detailed Description
This is a Phase I, single centre, open-label, randomised, two-way cross-over study in healthy volunteers to compare the bioavailability of two formulations of pyronaridine-artesunate, in tablet and in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01868438
Start Date
May 1 2013
End Date
January 1 2014
Last Update
December 18 2023
Active Locations (1)
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1
Dept. of Clinical Pharmacology and Therapeutics, Asan Medical Center, Univ. of Ulsan
Seoul, South Korea