WHO ICTRP trial
A Bioequivalence Study of Rivaroxaban Film-coated Tablets under Fasting…
TCTR20250710006 · Thai Clinical Trials Registry (TCTR) · Not Recruiting
Key facts
| Trial ID | TCTR20250710006 |
|---|---|
| Public title | A Bioequivalence Study of Rivaroxaban Film-coated Tablets under Fasting Condition |
| Scientific title | An open label, balanced, randomized, two-formulation, two-period, two-sequence, single oral dose, crossover, bioequivalence study of rivaroxaban 10 mg film-coated tablets of test formulation (REBLESS-10) of Mankind Pharma Limited, India with reference formulation (Xarelto 10 mg) of Bayer Thai Co… |
| 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 rivaroxaban formulations. Bioequivalence Healthy volunteers Generic rivaroxaban Pharmacokinetics;Bioequivalence Healthy volunteers Generic rivaroxaban… |
| Interventions | The subject who is assigned in Sequence 1 will receive REBLESS-10 (Test product) in Period 1 then Xarelto 10 mg (Reference product) in Period 2 while who is in Sequence 2 will receive Xarelto 10 mg (Reference product) following with… |
| Registration date | Oct 7, 2025 |
| Target size | 40 |
| Secondary IDs | Nil Known |
| Registry page | thaiclinicaltrials.org |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: