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NCT05436678 · ClinicalTrials.gov registry record · Phase 1
A Multiple-Dose PK Study to Evaluate the Comparative Bioavailability of PrimeC Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject
A Phase 1 study, sponsored by NeuroSense Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT05436678: Completed Phase 1 study, sponsored by NeuroSense Therapeutics.
NCT05436678 is a Phase 1 study that has completed, run by NeuroSense Therapeutics. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05436678, a Phase 1 study, has completed, sponsored by NeuroSense Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is an open-label, randomized, multiple-dose, two-treatment, two-period crossover study comparing the test and reference products. In each period of the study, either 2 × PrimeC tablets or reference products (ciprofloxacin co-administered celecoxib) will be administered to subjects every 12 hours for 6.5 days (13 total administrations), in fed conditions. The subjects will receive the test treatment in one of the study periods and the reference treatment in the other study period according to a two-sequence randomization schedule. Blood samples will be collected before the morning dose on Day 1, before the morning and evening dose on Days 5 and 6, before the morning dose on Day 7 and at intervals over 48 hours after the morning dose on Day 7 (see Section 7.6) in each study period. Subjects will be confined at the clinical facility from at least 10.5 hours before the initial dose on Day 1 until approximately 48 hours after the final dose on Day 7.
Primary Outcome
Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 1.
Interventions
- DRUG Ciprofloxacin 750 MG
- DRUG Celecoxib 200mg
- DRUG PrimeC 748 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-07-26 |
| Est. Completion | 2022-10-20 |
| Phase | Phase 1 |
What the finished NCT05436678 record still lists
NCT05436678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Ciprofloxacin 750 MG is the first listed.
NCT05436678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05436678 about?
NCT05436678 is a clinical study titled "A Multiple-Dose PK Study to Evaluate the Comparative Bioavailability of PrimeC Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject". This is an open-label, randomized, multiple-dose, two-treatment, two-period crossover study comparing the test and reference products. In each period of the study, either 2 × PrimeC tablets or reference products (ciprofloxacin co-administered celecoxib) will be administered to subjects every 12 hour...
What is the current status of trial NCT05436678?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2022-07-26. Estimated completion is 2022-10-20.
What interventions are being tested in trial NCT05436678?
The interventions under investigation include: Ciprofloxacin 750 MG (DRUG), Celecoxib 200mg (DRUG), PrimeC 748 mg (DRUG).
Who is sponsoring clinical trial NCT05436678?
This trial is sponsored by NeuroSense Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05436678's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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