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NCT05995119
Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy Volunteers
EARLY_PHASE1 trial testing Apixaban 5 mg Oral Dissolving Film (TAH3311) and Tablet (Eliquis®) in Healthy Volunteers in 12 participants. Completed in 13 January 2023.
28 December 2022
Quick facts
| Lead sponsor | TAHO Pharmaceuticals Ltd. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 12 |
| Start date | 5 December 2022 |
| Primary completion | 28 December 2022 |
| Estimated completion | 13 January 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Apixaban 5 mg Oral Dissolving Film (TAH3311) and Tablet (Eliquis®) — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Fasting — all drugs for Fasting →
- Fed — all drugs for Fed →
Sponsor
TAHO Pharmaceuticals Ltd. — full company profile →
Who can join
18 and older, any sex, with Healthy Volunteers or Fasting. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to evaluate the pharmacokinetic profiles and bioequivalence, and to determine the safety and tolerability of the TAH3311 Oral Dissolving Film (ODF) 5mg compared with ELIQUIS® (Apixaban) 5mg Oral Tablet, after single dose under fasted and fed conditions in healthy volunteers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05995119
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other TAHO Pharmaceuticals Ltd. trials
Trials by the same sponsor.
- NCT06689436 — Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers · Phase 2 · 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 NCT05995119 (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 TAHO Pharmaceuticals Ltd.
- Last refreshed: 18 August 2023
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/NCT05995119.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing