A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects
Status:
Not yet recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
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.