WHO ICTRP trial
A Bioequivalence study of a randomized, open-label, single dose, two-way…
TCTR20230915001 · Thai Clinical Trials Registry (TCTR) · Not Recruiting
Key facts
| Trial ID | TCTR20230915001 |
|---|---|
| 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 Linagliptin 2.5 mg and Metformin 500 mg Tablets relative to Trajenta Duo Tablets 2.5 mg/500 mg in Thai healthy volunteers under fed 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 Linagliptin 2.5 mg and Metformin 500 mg Film-coated Tablets relative to Trajenta Duo Film-coated Tablets 2.5 mg/500 mg in Thai healthy volunteers under fed… |
| 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 | Healthy subjects Bioequivalence Linagliptin 2.5 mg and Metformin 500 mg film-coated tablets;Bioequivalence Linagliptin 2.5 mg and Metformin 500 mg film-coated tablets |
| Interventions | The new generic products which were recently developed. Volunteer will receive a single dose of Linagliptin 2.5 mg and Metformin 500 mg Film-coated tablets with 240 mL of 20% glucose solution in water within 30 mins, The marketed original… |
| Registration date | Sep 15, 2023 |
| Target size | 40 |
| 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: