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A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects

Pharmacokinetics Clinical Trial

Official title:
A Pilot, Open-Label, Randomized, Single-Dose, Three-Treatment, Three-Period Crossover Study to Evaluate the Effect of Food on the Bioavailability of PrimeC-ER Tablets and the Comparative Bioavailability of PrimeC-ER and Ciprofloxacin Tablets and Celecoxib Capsules, When Co-Administered, in Healthy Adult Subjects

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05232461
Study type Interventional
Source NeuroSense Therapeutics Ltd.
Contact
Status Completed
Phase Phase 1
Start date April 8, 2022
Completion date August 30, 2022
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