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NCT01828827 · ClinicalTrials.gov registry record · Phase 1
Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects
A Phase 1 study, sponsored by Global Alliance for TB Drug Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01828827 is a Phase 1 study that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 16 participants.
The verdict
NCT01828827, a Phase 1 study, has completed, sponsored by Global Alliance for TB Drug Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824. This study was designed to understand the possible effects of a high-calorie, high-fat meal on PA-824 absorption and pharmacokinetics. The hypothesis to be tested in this study is that the rate and extent of absorption of PA-824, as measured by Tmax, Cmax, AUC(0-t), and AUC(0 inf), are the same after a high-calorie, high-fat meal as compared with after a minimum 10-hour fast.
Interventions
- DRUG PA-824 1000 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-03 |
| Est. Completion | 2007-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01828827
The ClinicalTrials.gov registry entry for NCT01828827 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Global Alliance for TB Drug Development, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PA-824 1000 mg is the first listed.
NCT01828827 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01828827 about?
NCT01828827 is a clinical study titled "Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects". This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824. This study was designed to understand the possible effects of a high-calorie, high-fat meal on P...
What is the current status of trial NCT01828827?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2007-03. Estimated completion is 2007-03.
What interventions are being tested in trial NCT01828827?
The interventions under investigation include: PA-824 1000 mg (DRUG).
Who is sponsoring clinical trial NCT01828827?
This trial is sponsored by Global Alliance for TB Drug Development, which has 13 total clinical trials registered on ClinicalTrials.gov.
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