WHO ICTRP trial
A Bioequivalence Study of Empagliflozin Tablets under Fasting Condition
TCTR20240924005 · Thai Clinical Trials Registry (TCTR) · Not Recruiting
Key facts
| Trial ID | TCTR20240924005 |
|---|---|
| Public title | A Bioequivalence Study of Empagliflozin Tablets 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 Test formulation (EMPAKIND 25) of Mankind Pharma Limited, India and reference formulation (Jardiance) of Boehringer Ingelheim (Thai) Ltd. in healthy Thai… |
| Primary sponsor | Mankind Pharma Ltd. |
| Secondary sponsors | Infinity Pharmaceutical Company Limited |
| 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 human volunteers to examine bioequivalence between two empagliflozin formulations. Bioequivalence Healthy volunteers;Bioequivalence Healthy volunteers |
| Interventions | A single dose of reference product for empagliflozin 25 mg is given to each subject after 10 hours of fasting. Reference product in this context refers to the product from original innovator marketed in Thailand.,A single dose of test… |
| Registration date | Sep 24, 2024 |
| Target size | 32 |
| Secondary IDs | Nil Known |
| Registry page | thaiclinicaltrials.org |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: