Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Group
Value
95% CI
Bexagliflozin Tablet Dosed in Fed Condition
176.1
± 30.6
Bexagliflozin Tablet Dosed in Fasted Condition
133.7
± 42.5
Tmax (Time of Maximum Observed Plasma Concentration)Primary· 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Group
Value
95% CI
Bexagliflozin Tablet Dosed in Fed Condition
5.0
3 – 8
Bexagliflozin Tablet Dosed in Fasted Condition
3.5
2 – 5
AUC0-t (Area Under the Plasma Concentration-time Curve From Time 0 to t)Primary· 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Group
Value
95% CI
Bexagliflozin Tablet Dosed in Fed Condition
1222.7
± 26.8
Bexagliflozin Dosed in Fasted Condition
1074.2
± 33.0
AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time 0 to ∞)Primary· 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose
Blood samples (2 mL) for bexagliflozin plasma concentrations were collected at 0 h (pre-dose), and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose (days 1-3 in treatment period 1 and days 8-10 in treatment period 2, respectively)
Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA).
Group
Value
95% CI
Bexagliflozin Tablet Dosed in Fed Condition
10.1
± 28.2
Bexagliflozin Dosed in Fasted Condition
11.7
± 38.0
Adverse events — posted to ClinicalTrials.gov
Time frame: The adverse event data were collected from Day 0 up to Day 10.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT03417076 — Absolute Bioavailability Study With Bexagliflozin
· Phase 1
· withdrawn
NCT03557658 — Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
· Phase 1
· completed
NCT03514641 — An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin for the Management of Essential Hypertension
· Phase 2, PHASE3
· completed
NCT03115112 — Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
· Phase 3
· completed
NCT03296800 — Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
· Phase 1
· completed
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Other Theracos trials
Trials by the same sponsor.
NCT03417076 — Absolute Bioavailability Study With Bexagliflozin
· Phase 1
· withdrawn
NCT03557658 — Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
· Phase 1
· completed
NCT03259789 — Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
· Phase 3
· completed
NCT03514641 — An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin for the Management of Essential Hypertension
· Phase 2, PHASE3
· completed
NCT03115112 — Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
· Phase 3
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Theracos
Last refreshed: 10 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02820298.