Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects
NCT05232461 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label, randomized, single-dose, three treatment, three-period crossover study comparing the test and reference products under fasted or fed conditions (as applicable). In one period of the study, PrimeC-ER tablets will be administered to subjects following an overnight fast of at least 10 hours. In a second period of the study, PrimeC-ER tablets will be administered to subjects at 30 minutes following the start of a standardized high-fat, high-calorie breakfast that was preceded by an overnight fast of at least 10 hours. In a third period of the study, a single 750 mg dose of ciprofloxacin and a single 200 mg dose of celecoxib will be co-administered to subjects following an overnight fast of at least 10 hours. The order of administration will follow a six-sequence randomization schedule. Blood samples will be collected at pre-dose and at intervals over 48 hours after dosing in each study period. Subjects will be confined at the clinical facility from at least 10.5 hours before dosing until 48 hours after dosing in each study period. The interval between doses will be at least 7 days. Subjects will return to the clinical facility 7 days (± 1 day) after the last study drug administration for an end-of study follow-up visit.
Conditions Studied
Interventions
- DRUG PrimeC-ER 748 mg
- DRUG Ciprofloxacin 750 MG
- DRUG Celecoxib 200mg
Study Locations (1)
North Dakota
- Novum — Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-04-08 |
| Est. Completion | 2022-08-30 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05232461
The ClinicalTrials.gov registry entry for NCT05232461 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 NeuroSense Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 3 interventions — of which PrimeC-ER 748 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05232461 reports 1 study location spanning 1 distinct geographic area — top geographies include North Dakota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05232461 about?
NCT05232461 is a clinical study titled "A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects". This is an open-label, randomized, single-dose, three treatment, three-period crossover study comparing the test and reference products under fasted or fed conditions (as applicable). In one period of the study, PrimeC-ER tablets will be administered to subjects following an overnight fast of at lea...
What is the current status of trial NCT05232461?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-04-08. Estimated completion is 2022-08-30.
What conditions does trial NCT05232461 study?
This clinical trial studies the following conditions: Pharmacokinetics. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05232461?
The interventions under investigation include: PrimeC-ER 748 mg (DRUG), Ciprofloxacin 750 MG (DRUG), Celecoxib 200mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05232461?
This trial is sponsored by NeuroSense Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05232461 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.