WHO ICTRP trial

A Bioequivalence study of a randomized, open-label, single dose, two-way…

TCTR20250608005 · Thai Clinical Trials Registry (TCTR) · Not Recruiting

Key facts

Trial ID TCTR20250608005
Public title A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Dapagliflozin Tablet 10 mg relative to Originator Dapagliflozin Tablet 10 mg in healthy Thai volunteers under fasting condition
Scientific title A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Dapagliflozin Tablet 10 mg relative to Originator Dapagliflozin Tablet 10 mg in healthy Thai volunteers under fasting condition
Primary sponsor Bio-innova Co., Ltd.
Registry Thai Clinical Trials Registry (TCTR)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 1
Countries Thailand
Conditions The study is conducted in healthy Thai human volunteers to improve glycemic Bioequivalence Dapagliflozin Tablet 10 mg;Bioequivalence Dapagliflozin Tablet 10 mg
Interventions The new generic products which were recently developed. Volunteer will receive a single dose of Dapagliflozin Tablet 10 mg with 240 mL of 20% w/v glucose solution in water,The marketed original products which were already available in the…
Registration date Aug 6, 2025
Target size 36
Secondary IDs Nil Known
Registry page thaiclinicaltrials.org

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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