Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Febuxostat F1 · 1 trial · 1 indication
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...
Febuxostat F1 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its relative bioavailability. The drug is not approved for any indication and remains under investigation.
Febuxostat F1 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.
Febuxostat F1 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under study in healthy volunteers.
Febuxostat F1 has one completed Phase 1 trial, NCT02504320, titled "Phase 1, Febuxostat XR Relative Bioavailability Study." The trial enrolled 78 healthy volunteers in the United States, with participants aged 18 years and older, and included both sexes.
Febuxostat F1 appears to be related to Febuxostat XR, as the completed clinical trial NCT02504320 is titled "Phase 1, Febuxostat XR Relative Bioavailability Study." The study evaluates the relative bioavailability of the drug, suggesting Febuxostat F1 may be an extended-release formulation.