Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT02789566
Brief Summary:
The primary objective of this study is to provide a description of the pharmacokinetic properties of primaquine and metabolites and characterize these in healthy obese Thai subjects.
This is an open-label, single dose pharmacokinetic study in 10 healthy obese G6PD normal, subjects will be admitted as inpatient to receive 1 regimen for 1 visit only.
Detailed Description:
Subjects will have 1 hospitalization. The visit will require hospitalization for about 24 hours. After the screening (visit 1), the subject will receive Primaquine (PQ) 30 mg base single dose at first admission (visit 2). Assessment of the safety profile will be done after admission by the investigating team before proceeding to the regimen.
The study will enroll 10 healthy obese subjects (Body mass index \[BMI\] ≥30 kg/m2) both male and female, age 18-60 years, from the pharmacokinetic unit at Faculty of Tropical Medicine, Mahidol University. Participants will be healthy HIV-1, hepatitis B and C uninfected individuals who comprehend the purpose of the study and have provided written consent. Participants will be screened and eligibility will be based on inclusion and exclusion criteria. If all doses are completed without replacement of subjects, the total number of subjects in this study is 10. All subjects will undergo screening assessments within 7 days prior to the single dose to determine their eligibility for enrollment into the study.
Study:
NCT02789566
Study Brief:
Protocol Section:
NCT02789566