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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 is a Phase 1 study that has completed, run by NeuroSense Therapeutics. The registered enrollment target is 19 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05436678
The ClinicalTrials.gov registry entry for NCT05436678 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NeuroSense Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ciprofloxacin 750 MG is the first listed.
NCT05436678 reports 0 study locations.
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.
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