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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01496443 | TAK-875 Glimepiride Drug-Interaction Study | PHASE1 | COMPLETED | 28 | — | — | Jan 1, 2012 | May 1, 2012 | Sep 13, 2012 | 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.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
AUC(0-inf) is measure of area under the plasma concentration-time curve from time 0 to infinity after drug administration.
AUC(0-24) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval - 24 hours in this study).
| Arm | Type | Description |
|---|---|---|
| TAK-875 & Glimepiride QD | EXPERIMENTAL | TAK-875 50 mg, tablets, orally and glimepiride 2 mg, capsules, orally and glimepiride placebo matching capsules, orally, once daily on dosing days for up to 19 days. |
| Name | Type | Description |
|---|---|---|
| TAK-875 and Glimepiride | DRUG | - |
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...