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This is a Phase I, open-label, randomized, four-treatment period, four-sequence, single-dose, crossover pharmacokinetic study to determine the bioequivalence of pirfenidone after administration of tablet and capsule dosage forms under both fed and fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirfenidone ACBD treatment sequence | Experimental | Participants will be given 801 milligrams (mg) single oral doses of pirfenidone on Days 1, 4, 7 and 10 during the study. Participants will be administered, capsules (3 x 267-mg capsule) in fed state (treatment A) on Day 1 and in fasted state (treatment C) on Day 4, 801-mg tablet in fed state (treatment B) on Day 7 and in fasted state (treatment D) on Day 10. |
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| Pirfenidone BADC treatment sequence | Experimental | Participants will be given 801 mg single oral doses of pirfenidone on Days 1, 4, 7 and 10 during the study. Participants will be administered, 801-mg tablet in fed state (treatment B) on Day 1, capsules (3 x 267-mg capsule) in fed state (treatment A) on Day 4, 801-mg tablet in fasted state (treatment D) on Day 7 and capsules (3 x 267-mg capsule) in fasted state (treatment C) on Day 10. |
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| Pirfenidone CDAB treatment sequence | Experimental | Participants will be given 801 mg single oral doses of pirfenidone on Days 1, 4, 7 and 10 during the study. Participants will be administered, capsules (3 x 267-mg capsule) in fasted state (treatment C) on Day 1, 801-mg tablet in fasted state (treatment D) on Day 4, capsules (3 x 267-mg capsule) in fed state (treatment A) on Day 7 and 801-mg tablet in fed state (treatment B) on Day 10. |
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| Pirfenidone DBCA treatment sequence | Experimental | Participants will be given 801 mg single oral doses of pirfenidone on Days 1, 4, 7 and 10 during the study. Participants will be administered, 801-mg tablet in fasted state (treatment D) on Day 1 and in fed state (treatment C) on Day 4, capsules (3 x 267-mg capsule) in fasted state (treatment C) on Day 7 and in fed state (treatment A) on Day 10. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | Pirfenidone 801 mg single oral doses will be given either in the form of tablet or capsules under fed or fasted conditions on Days 1, 4, 7 and 10. |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of Pirfenidone | 11 days | |
| Area Under the Plasma Concentration Versus Time Curve (AUC) from Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Pirfenidone | 11 days | |
| AUC from Time Zero to Infinity (AUC[0-inf]) of Pirfenidone | 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of AUC(0-t) to AUC(0-inf) of Pirfenidone | 11 days | |
| Terminal Elimination Rate Constant of Pirfenidone | 11 days | |
| Apparent Terminal Half-Life (t1/2) of Pirfenidone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merritt Island | Florida | 32953 | United States |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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| 11 days |
| Time to Peak Plasma Concentration of Pirfenidone | 11 days |