WHO ICTRP trial
A Bioequivalence study of a randomized, open-label, single dose, fully…
TCTR20240830001 · Thai Clinical Trials Registry (TCTR) · Not Recruiting
Key facts
| Trial ID | TCTR20240830001 |
|---|---|
| Public title | A Bioequivalence study of a randomized, open-label, single dose, fully replicated crossover design with four-period, two-treatment, and two-sequence of Dabigatran Etexilate capsules 150 mg relative to PRADAXA 150 MG in healthy Thai volunteers under fasting condition. |
| Scientific title | A Bioequivalence study of a randomized, open-label, single dose, fully replicated crossover design with four-period, two-treatment, and two-sequence of Dabigatran Etexilate capsules 150 mg relative to PRADAXA 150 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 prevented anticoagulant. Bioequivalence Dabigatran Etexilate capsules 150 mg ;Bioequivalence Dabigatran Etexilate capsules 150 mg |
| Interventions | The new generic products which were recently developed. Volunteer will receive a single dose of Dabigatran Etexilate capsules 150 mg with 250 mL of drinking water and at least 7 days washout period between the doses The order of product… |
| Registration date | Aug 30, 2024 |
| Target size | 44 |
| 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: