drugset / Trial / NCT06233045

Dapagliflozin Tablet 10 mg Relative to Forxiga® Tablets 10 mg

NCT06233045

Phase 1 Unknown 30 enrolled Bio-innova Co., Ltd
RandomizedCrossoverOpen-labelBasic science

Summary

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 5 days washout period between the doses.

Timeline

Start
2024-07-23
Primary completion
2024-08-25
Completion
2024-09-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg Oral

Indications

No indication recorded.