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NCT01830439 · ClinicalTrials.gov registry record · Phase 1
Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009)
A Phase 1 study, sponsored by Global Alliance for TB Drug Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01830439 is a Phase 1 study that has completed, run by Global Alliance for TB Drug Development. The registered enrollment target is 32 participants.
The verdict
NCT01830439, a Phase 1 study, has completed, sponsored by Global Alliance for TB Drug Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This will be a Phase 1, single-center, randomized, balanced, single-dose, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824. The hypothesis to be tested in this study is that the rate and extent of absorption of two doses of PA-824 (50mg or 400 mg and 200mg) are the same after a high-calorie, high-fat meal as compared with after a minimum 10-hour fast. For each of the two dose levels 16 subjects with approximately 8 men and 8 women, will be enrolled for a total of 32 subjects.
Interventions
- DRUG PA-824 200mg
- DRUG PA-824 50mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01830439
The ClinicalTrials.gov registry entry for NCT01830439 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 2 interventions - of which PA-824 200mg is the first listed.
NCT01830439 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01830439 about?
NCT01830439 is a clinical study titled "Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009)". This will be a Phase 1, single-center, randomized, balanced, single-dose, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824. The hypothesis to be tested in this study is that the rate and extent of absorption of two doses of PA-824...
What is the current status of trial NCT01830439?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2009-09. Estimated completion is 2010-01.
What interventions are being tested in trial NCT01830439?
The interventions under investigation include: PA-824 200mg (DRUG), PA-824 50mg (DRUG).
Who is sponsoring clinical trial NCT01830439?
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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