Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05436678 | 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 | PHASE1 | COMPLETED | 19 | — | — | Jul 26, 2022 | Oct 20, 2022 | Feb 8, 2023 | 1 | United States |
| NCT05232461 | A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects | PHASE1 | COMPLETED | 12 | — | — | Apr 8, 2022 | Aug 30, 2022 | Oct 25, 2022 | 1 | United States |
Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 1.
Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 7.
Area under the plasma concentration versus time curve from time zero to the end of the morning 12-hour dosing interval on Day 1, as calculated by the linear trapezoidal method.
Area under the plasma concentration time curve over the morning 12-hour dosing interval on Day 7, as calculated by the linear trapezoidal method.
AUC is tested in order to assess the effect of food on the bioavailability of PrimeC-ER Tablets (748 mg) in healthy adult male and female subjects, and in order to evaluate the comparative bioavailability of PrimeC-ER Tablets (748 mg) relative to a 750 mg dose of ciprofloxacin tablets and a 200 mg dose of celecoxib capsules, when co-administered, under fasted conditions in healthy adult male and female subjects.
AUC is tested in order to assess the effect of food on the bioavailability of PrimeC-ER Tablets (748 mg) in healthy adult male and female subjects, and in order to evaluate the comparative bioavailability of PrimeC-ER Tablets (748 mg) relative to a 750 mg dose of ciprofloxacin tablets and a 200 mg dose of celecoxib capsules, when co-administered, under fasted conditions in healthy adult male and female subjects.
Cmax is tested in order to assess the effect of food on the bioavailability of PrimeC-ER Tablets (748 mg) in healthy adult male and female subjects, and in order to evaluate the comparative bioavailability of PrimeC-ER Tablets (748 mg) relative to a 750 mg dose of ciprofloxacin tablets and a 200 mg dose of celecoxib capsules, when co-administered, under fasted conditions in healthy adult male and female subjects.
| Arm | Type | Description |
|---|---|---|
| PrimeC | ACTIVE_COMPARATOR | 2 PrimeC tablets (total single dose 748 mg) twice daily for 6.5 days following a meal |
| Marketed ciprofloxacin and celecoxib | ACTIVE_COMPARATOR | 750 mg of ciprofloxacin and 200 mg of celecoxib, co-administered twice daily for 6.5 days following a meal |
| PrimeC ER Fasted | ACTIVE_COMPARATOR | Single dose PrimeC-ER (748 mg), administered following an overnight fast of at least 10 hours. |
| PrimeC ER Meal | ACTIVE_COMPARATOR | Single dose PrimeC-ER (748 mg), administered at 30 minutes after the start of a standardized high-fat, high-calorie breakfast that was preceded by an overnight fast of at least 10 hours. |
| Name | Type | Description |
|---|---|---|
| PrimeC 748 mg | DRUG | PrimeC is an extended release formulation of a fixed dose combination of ciprofloxacin and celecoxib |
| Ciprofloxacin 750 MG | DRUG | Ciprofloxacin |
| Celecoxib 200mg | DRUG | Celecoxib |
| PrimeC-ER 748 mg | DRUG | PrimeC-ER is an extended release formulation of a fixed dose combination of ciprofloxacin and celecoxib |
Inclusion Criteria: 1. Males and females, 18-55 years of age, inclusive, with a Body Mass Index (BMI) of 18.5-29.9 kg/m², inclusive. 2. Female subjects must meet at least one of the following criterion: * Agree to abstain from sexual intercourse from screening and throughout the duration of the...