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Clinical Trial Details

Trial ID: L4218
Source ID: NCT03197324
Associated Drug: Bexagliflozin
Title: Bexagliflozin Drug/Drug Interaction Study With Digoxin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03197324/results
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: Bexagliflozin|DRUG: Digoxin
Outcome Measures: Primary: Digoxin Cmax (Maximum Observed Plasma Concentration), Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin, Up to 120 hours|Digoxin Tmax (Time of Maximum Observed Plasma Concentration), Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin, Up to 120 hours|Digoxin T1/2 (Apparent Terminal Elimination Half-life), Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin, Up to 120 hours|AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity), Blood samples for pharmacokinetic parameters were drawn at pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h after administration of digoxin, Up to 120 hours |
Sponsor/Collaborators: Sponsor: Theracos
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-07-24
Completion Date: 2017-09-17
Results First Posted: 2021-07-16
Last Update Posted: 2021-07-23
Locations: Covance CRU, Daytona Beach, Florida, 32117, United States
URL: https://clinicaltrials.gov/show/NCT03197324