This study is currently not recruiting participants.

009/07; Bioequivalence Trial of Pyronaridine:Artesunate to-be-Marketed Tablet to the Clinical Trial Reference Tablet

Study on Bioequivalence of Investigational Medication

Not Recruiting
18 years - 45 years
All
Phase N/A

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
  • Age: 18 years - 45 years
  • 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.
Updated on 19 Feb 2024. Study ID: 1005-69 (1010002768)

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