The new generic products which were recently developed. Volunteer will receive a single dose of Dapagliflozin Tablet 10 mg of either test or reference with 240 mL of 20% w/v glucose solution in water.
Sponsors
Bio-innova Co., Ltd.
Conditions
Healthy subjects
Bioequivalence Dapagliflozin Tablet 10 mgThe study is conducted in healthy Thai human volunteers to improve glycemic
Bioequivalence Dapagliflozin Tablet 10 mg
Phase 1
A randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence bioequivalence study of Dapagliflozin Tablet 10 mg relative to Originator FORXIGA (Dapagliflozin) tablets 10 mg in healthy Thai volunteers under fasting condition
TCTR20240524007
Start: 2024-11-12Target: 42Updated: 2026-08-03
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Dapagliflozin tablets 10 mg relative to Forxiga 10 mg tablets in healthy Thai volunteers under fasting condition
TCTR20241120003
Start: 2025-02-11Target: 36Updated: 2026-08-03
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Dapagliflozin Tablets 10 mg in healthy adult human subjects under fasted conditions
TCTR20241220001
Start: 2025-05-06Target: 36Updated: 2026-08-03