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NCT04729998
Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 20 mg in Healthy Male Volunteers Under Fed Conditions
Phase 1 trial testing Rivaroxaban film-coated tablet 20 mg in Bioequivalence in 34 participants. Status unknown.
15 February 2021
Quick facts
| Lead sponsor | Pharmtechnology LLC |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 34 |
| Start date | 30 January 2021 |
| Primary completion | 15 February 2021 |
| Estimated completion | 15 February 2021 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Rivaroxaban film-coated tablet 20 mg — full drug profile →
- Xarelto® film-coated tablet 20 mg — full drug profile →
Conditions studied
- Bioequivalence — all drugs for Bioequivalence →
Sponsor
Pharmtechnology LLC — full company profile →
Who can join
Adults 18 to 45, male only, with Bioequivalence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 20 mg film-coated tablets) or the test (Rivaroxaban, 20 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04729998
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Pharmtechnology LLC trials
Trials by the same sponsor.
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- NCT05940909 — Bioequivalence Study of Perindopril /Amlodipine/Indapamide 8 mg (10 mg)/2.5 mg/10 mg Tablets in Healthy Volunteers Under · Phase 1 · unknown
- NCT05934799 — Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting · Phase 1 · completed
- NCT05685277 — Bioequivalence Study of Two Formulations of Tablets Ramipril/Hydrochlorothiazide 10 mg/25 mg in Healthy Volunteers Under · Phase 1 · completed
- NCT05642845 — Bioequivalence Study of Two Formulations of Atorvastatin Film-coated Tablets 40 mg in Healthy Volunteers Under Fasting C · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04729998 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pharmtechnology LLC
- Last refreshed: 29 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04729998.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing