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NCT01875939 · ClinicalTrials.gov registry record · Phase 1
Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers
A Phase 1 study, sponsored by Wockhardt.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01875939 is a Phase 1 study that has completed, run by Wockhardt. The registered enrollment target is 12 participants.
The verdict
NCT01875939, a Phase 1 study, has completed, sponsored by Wockhardt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose). This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK 2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771, IV to WCK 2349, oral) in future clinical trials in patients.
Interventions
- DRUG Oral WCK2349
- DRUG IV WCK771
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01875939
The ClinicalTrials.gov registry entry for NCT01875939 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wockhardt, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oral WCK2349 is the first listed.
NCT01875939 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01875939 about?
NCT01875939 is a clinical study titled "Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers". This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose). This study would ascertain/confirm the therapeutically equivalent oral and IV dos...
What is the current status of trial NCT01875939?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2013-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01875939?
The interventions under investigation include: Oral WCK2349 (DRUG), IV WCK771 (DRUG).
Who is sponsoring clinical trial NCT01875939?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
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