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Clinical Trial Details

Trial ID: L2710
Source ID: NCT02956044
Associated Drug: Bexagliflozin
Title: Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02956044/results
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: Bexagliflozin|DRUG: Metformin|DRUG: Glimepiride|DRUG: Sitagliptin
Outcome Measures: Primary: Cmax (Maximum Observed Plasma Concentration), Whole venous blood samples of 5 mL were be collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. Pharmacokinetic (PK) blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. Cmax was obtained directly from experimental observations., Up to 72 hours|Tmax (Time of Maximum Observed Plasma Concentration), Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. Tmax was obtained directly from experimental observations., Up to 72 hours|T1/2 (Apparent Terminal Elimination Half-life), Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. T1/2 was obtained directly from experimental observations., Up to 72 hours|AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity), Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. AUC0-inf was estimated for each subject., Up to 72 hours | Secondary: Urinary Glucose Excretion up to 0-72 hr, Pre-dose urine samples were collected from -12 to 0 h for baseline measurement. Subjects was instructed to empty their bladder prior to dosing. Post-dose urine was collected in 4 batches for Groups 1 and 2 at 0 to 12 h, 12 to 24 h, 24 o 36 h, and 36 to 48 h collections. Post-dose urine was collected in batches for Group 3 at 0 to 12 h, 12 to 24 h, 24 to 36 h, 36 to 48 h, 48 to 60 h and 60 to 72 h., up to 0-72 hr
Sponsor/Collaborators: Sponsor: Theracos
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 54
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-11
Completion Date: 2017-03
Results First Posted: 2021-07-22
Last Update Posted: 2021-07-22
Locations: Clinical Research Site, Evansville, Indiana, 47710, United States
URL: https://clinicaltrials.gov/show/NCT02956044