NCT05232461

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: NeuroSense Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	PrimeC-ER 748 mg	PrimeC-ER is an extended release formulation of a fixed dose combination of ciprofloxacin and celecoxib
DRUG	Ciprofloxacin 750 MG	Ciprofloxacin
DRUG	Celecoxib 200mg	Celecoxib

Timeline

• Start date: 2022-04-08
• Primary completion: 2022-04-21
• Completion: 2022-08-30
• First posted: 2022-02-09
• Last updated: 2022-10-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study