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This is an open-label, randomized, multiple-dose, two-treatment, two-period crossover study comparing the test and reference products. In each period of the study, either 2 × PrimeC tablets or reference products (ciprofloxacin co-administered celecoxib) will be administered to subjects every 12 hours for 6.5 days (13 total administrations), in fed conditions.
The subjects will receive the test treatment in one of the study periods and the reference treatment in the other study period according to a two-sequence randomization schedule. Blood samples will be collected before the morning dose on Day 1, before the morning and evening dose on Days 5 and 6, before the morning dose on Day 7 and at intervals over 48 hours after the morning dose on Day 7 (see Section 7.6) in each study period. Subjects will be confined at the clinical facility from at least 10.5 hours before the initial dose on Day 1 until approximately 48 hours after the final dose on Day 7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrimeC 748 mg | Drug | PrimeC is an extended release formulation of a fixed dose combination of ciprofloxacin and celecoxib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax D1 | Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 1. | 1 day |
| Cmax D7 | Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 7. | 7 days |
| AUC0-12 D1 | 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. | 1 day |
| AUC0-12 D7 | Area under the plasma concentration time curve over the morning 12-hour dosing interval on Day 7, as calculated by the linear trapezoidal method. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cpre Dx | Measured pre-dose plasma concentration on Days 1, 5, 6 and 7; where D = Day 1, 5, 6 or 7; and x = m (morning dose) or e (evening dose). | 7 days |
| Tmax D1 | Time of the maximum measured plasma concentration on Day 1 over the morning 12-hour dosing interval on Day 1. |
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Inclusion Criteria:
Males and females, 18-55 years of age, inclusive, with a Body Mass Index (BMI) of 18.5-29.9 kg/m², inclusive.
Female subjects must meet at least one of the following criterion:
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
Signed and dated informed consent form, which meets all criteria of current FDA regulations.
Subject understands the requirements of the study and is willing to comply with all study requirements.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novum | Las Vegas | Nevada | 89121 | United States |
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| Ciprofloxacin 750 MG | Drug | Ciprofloxacin |
|
| Celecoxib 200mg | Drug | Celecoxib |
|
| 1 day |
| AR Treatment R | For Treatment R (reference products), the ratio of accumulation over the morning 12-hour dosing interval on Day 7 compared the morning 12-hour dosing interval on Day 1 will be determined by the formula, (AUC0-12,D7 / AUC0-12,D1). | 7 days |
| AR Treatment T | For Treatment T (PrimeC), the ratio of accumulation over the morning 12-hour dosing interval on Day 7 compared the morning 12-hour dosing interval on Day 1 will be determined by the formula, (AUC0-12,D7 / AUC0-12,D1). | 7 days |
| Cav D7 | Average measured plasma concentration over the morning 12-hour dosing interval on Day 7. | 7 days |
| Cmin D7 | Minimum measured plasma concentration over the morning 12-hour dosing interval on Day 7. | 7 days |
| Ctrough D7 | Measured plasma concentration at the end of the morning dosing interval on Day 7. | 7 days |
| Tmax D7 | Time of the maximum measured plasma concentration over the morning 12-hour dosing interval on Day 7. | 7 days |
| λz | First order rate constant associated with the terminal (log-linear) portion of the curve following the last dose administered on the morning of Day 7. | 7 days |
| t½ | The terminal half-life following the last dose administered on the morning of Day 7 | 7 days |
| Percent Fluctuation | Percent fluctuation over the morning 12-hour dosing interval on Day 7 | 7 days |
| Percent Swing | Percent swing over the morning 12-hour dosing interval on Day 7 | 7 days |
| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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