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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02504320 | Phase 1, Febuxostat XR Relative Bioavailability Study | PHASE1 | COMPLETED | 78 | — | — | Aug 1, 2015 | Oct 1, 2015 | Jan 19, 2017 | 1 | United States |
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.
AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence ABDC | EXPERIMENTAL | Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C). |
| Treatment Sequence DACB | EXPERIMENTAL | Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B). |
| Treatment Sequence CDBA | EXPERIMENTAL | Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A). |
| Treatment Sequence BCAD | EXPERIMENTAL | Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D). |
| Name | Type | Description |
|---|---|---|
| Febuxostat XR 80 mg Capsule F1 | DRUG | Febuxostat extended-release (XR) capsules formulation 1 |
| Febuxostat XR 80 mg Capsule F2 | DRUG | Febuxostat XR capsules formulation 2 |
| Febuxostat XR 80 mg Capsule F3 | DRUG | Febuxostat XR capsules formulation 3 |
| Febuxostat XR 80 mg Capsule F4 | DRUG | Febuxostat XR capsules formulation 4 |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...