009/07; Bioequivalence Trial of Pyronaridine:Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet
Study on Bioequivalence of Investigational Medication
Brief description of study.
The purpose 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.
Detailed description of study
The purpose 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Malaria
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Age: 18 years - 45 years
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Gender: All
This study investigates the bioequivalence of a combination tablet containing two active ingredients, pyronaridine and artesunate, in healthy adults. Bioequivalence means that two drugs have similar bioavailability and effects on the body. The study compares a to-be-marketed tablet with a clinical trial reference tablet, both given as a single dose.
Participants in the study will receive a single dose of the investigational medication, which is a combination of pyronaridine and artesunate. The study will measure how the drug is absorbed, distributed, metabolized, and excreted in the body to determine if the two tablet forms are bioequivalent.
- Who can participate: Participants should be healthy adults, typically within a specific age range, as determined by the study's eligibility criteria.
- Study details: Participants will take a single dose of the investigational medication. The study will involve monitoring how the drug behaves in the body.
Interested in the study?
Select a study center that’s convenient for you, and get in touch with the study team.
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