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A Phase 1, Single-Blind, Placebo Controlled, Sequential Design Study to Evaluate the Drug Interaction Potential Between Glimepiride and TAK-875 in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to determine the pharmacokinetics and safety of TAK-875, once daily (QD), with and without glimepiride in participants with type 2 diabetes mellitus (T2DM).
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 28 |
| Start date | 2012-01 |
| Completion | 2012-05 |
Conditions
- Pharmacokinetics
Interventions
- TAK-875 and Glimepiride
Primary outcomes
- Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter for TAK-875 — Day 17 and Day 18.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. - Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter for Glimepiride — Day 1 and Day 18.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. - Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter for TAK-875 — Day 17 and Day 18.
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. - Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter for Glimepiride — Day 1 and Day 18.
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax - AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter for Glimepiride — Day 1 and Day 18.
(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): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity Pharmacokinetic Parameter for Glimepiride — Day 1 and Day 18.
AUC(0-inf) is measure of area under the plasma concentration-time curve from time 0 to infinity after drug administration.
Countries
United States