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Clinical Trial Details

Trial ID: L5226
Source ID: NCT01496443
Associated Drug: Tak-875 And Glimepiride
Title: TAK-875 Glimepiride Drug-Interaction Study
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Pharmacokinetics
Interventions: DRUG: TAK-875 and Glimepiride
Outcome Measures: Primary: Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter for TAK-875, Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve., Day 17 and Day 18.|Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter for Glimepiride, Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve., Day 1 and Day 18.|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter for TAK-875, Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax., Day 17 and Day 18.|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter for Glimepiride, Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, Day 1 and Day 18.|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, (AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\])., Day 1 and Day 18.|AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity Pharmacokinetic Parameter for Glimepiride, AUC(0-inf) is measure of area under the plasma concentration-time curve from time 0 to infinity after drug administration., Day 1 and Day 18.|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter for TAK-875, 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)., Day 17 and Day 18. |
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose:
Start Date: 2012-01
Completion Date: 2012-05
Results First Posted:
Last Update Posted: 2012-09-13
Locations: San Antonio, Texas, United States
URL: https://clinicaltrials.gov/show/NCT01496443