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NCT06806995 · ClinicalTrials.gov registry record · Phase 1
A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.
A Phase 1 study of PHA1A, sponsored by Wockhardt.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06806995: Completed Phase 1 study of PHA1A, sponsored by Wockhardt.
NCT06806995 is a Phase 1 study of PHA1A that has completed, run by Wockhardt. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06806995, a Phase 1 study of PHA1A, has completed, sponsored by Wockhardt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I, Single-Center, Open-Label study evaluating the safety and pharmacokinetics of single doses of ZID-FEP and metronidazole alone or in combination utilizing a 3-period, crossover study design. Thirty eligible male and female healthy adult subjects will participate in the study and receive single doses of (1) ZID-FEP 3g IV (ZID 1 g plus FEP 2 g) administered over 1 hour (h); (2) metronidazole 0.5 g IV alone administered over 1 h; and (3) metronidazole 0.5 g IV over 1 h, followed by ZID-FEP 3g IV over 1 h over 3 treatment periods separated by a 48 h washout period.
Primary Outcome
Maximum concentration (Cmax)
Conditions Studied
Interventions
- DRUG Metronidazole
- DRUG Zidebactam-Cefepime
- DRUG FEP-ZID
Study Locations (1)
Florida
- Advanced Pharma CR, LLC - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-01-21 |
| Est. Completion | 2025-02-17 |
| Phase | Phase 1 |
What the finished NCT06806995 record still lists
NCT06806995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with PHA1A appearing as the primary indexed condition, and to 3 interventions - of which Metronidazole is the first listed.
NCT06806995 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06806995 about?
NCT06806995 is a clinical study titled "A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.". This is a Phase I, Single-Center, Open-Label study evaluating the safety and pharmacokinetics of single doses of ZID-FEP and metronidazole alone or in combination utilizing a 3-period, crossover study design. Thirty eligible male and female healthy adult subjects will participate in the study and re...
What is the current status of trial NCT06806995?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-01-21. Estimated completion is 2025-02-17.
What conditions does trial NCT06806995 study?
This clinical trial studies the following conditions: PHA1A.
What interventions are being tested in trial NCT06806995?
The interventions under investigation include: Metronidazole (DRUG), Zidebactam-Cefepime (DRUG), FEP-ZID (DRUG).
Who is sponsoring clinical trial NCT06806995?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06806995 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06806995's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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