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NCT03622008 · ClinicalTrials.gov registry record · Phase 1
To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)
A Phase 1 study of Antibiotics Causing Adverse Effects in Therapeutic Use, sponsored by Wockhardt.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03622008: Completed Phase 1 study of Antibiotics Causing Adverse Effects in Therapeutic Use, sponsored by Wockhardt.
NCT03622008 is a Phase 1 study of Antibiotics Causing Adverse Effects in Therapeutic Use that has completed, run by Wockhardt. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03622008, a Phase 1 study of Antibiotics Causing Adverse Effects in Therapeutic Use, has completed, sponsored by Wockhardt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult volunteers for 10 days.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG FEP-TAZ 4 g
Study Locations (1)
Wisconsin
- Spaulding Clinical Research - West Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-03-23 |
| Est. Completion | 2018-05-30 |
| Phase | Phase 1 |
What the finished NCT03622008 record still lists
NCT03622008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Antibiotics Causing Adverse Effects in Therapeutic Use appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03622008 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03622008 about?
NCT03622008 is a clinical study titled "To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)". To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult volunteers for 10 days.
What is the current status of trial NCT03622008?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-03-23. Estimated completion is 2018-05-30.
What conditions does trial NCT03622008 study?
This clinical trial studies the following conditions: Antibiotics Causing Adverse Effects in Therapeutic Use.
What interventions are being tested in trial NCT03622008?
The interventions under investigation include: Placebo (OTHER), FEP-TAZ 4 g (DRUG).
Who is sponsoring clinical trial NCT03622008?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03622008 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03622008's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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