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A study to characterize the single-dose and steady-state pharmacokinetics of tofacitinib Modified Release (MR) formulation as well as to compare the extent of absorption of the MR 11 mg formulation (once daily) to that of the Immediate Release (IR) 5 mg formulation (twice daily) of tofacitinib in Chinese healthy subjects under fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A, separated washout phase, followed Treatment B. | Experimental | Treatment A: Single oral dose of tofacitinib MR 11mg, administered as 1xMR 11mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7. washout phase: no later than 72 hours Treatment B: Two separate oral doses (12 hours apart) of tofacitinib IR 5mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7. |
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| Treatment B, separated washout phase, followed Treatment A. | Experimental | Treatment A: Single oral dose of tofacitinib MR 11mg, administered as 1xMR 11mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7. Washout phase: no later than 72 hours Treatment B: Two separate oral doses (12 hours apart) of tofacitinib IR 5mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tofacitinib MR 11 mg | Drug | Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration time profile from time zero extrapolated to infinite time (AUCinf) | Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment. | |
| Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast) | Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment. | |
| Area under the concentration time profile for the 24 hour period (AUC24) | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Single-dose PK: maximum observed concentration (Cmax) | Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment. | |
| Single-dose PK: time for Cmax (Tmax) | Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuguang Hospital Affiliated to Shanghai University of TCM/Phase I Unit | Shanghai | 201203 | China |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Subjects will be randomized to one of the two treatment sequences. Each treatment sequence will consist of two periods, separated by a washout phase of no less than 72 hours from the AM dose on Day 7.
Treatment A (Test): Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.
Treatment B (Reference): Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
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| tofacitinib IR 5 mg | Drug | Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7. |
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| Single-dose PK: terminal half-life (t1/2) | Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment. |
| Single-dose PK: area under the plasma concentration-time profile from time 0 to tau (AUCtau) | Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment. |
| Steady-state PK: Cmax | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Steady-state PK: lowest concentration observed (Cmin) | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Steady-state PK: average concentration (Cav) | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Steady-state PK: Tmax | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Steady-state PK: concentration at 24 hours (C24) | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Steady-state PK: peak to trough ratio (PTR) | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Steady-state PK: peak to trough fluctuation (PTF) | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Steady-state PK: peak to trough swing (PTS) | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Steady-state PK: observed accumulation ratio for AUC (Rac) | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Steady-state PK: observed accumulation ratio for Cmax (Rac,Cmax) | Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose) |
| Number (%) of subjects with treatment-emergent adverse events | ECG, Clinical Laboratories, Vitals Signs and Physical Exams will be used as a safety measure to detect any AEs. | approximately 18 days |