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NCT04671316
Bioequivalence Study Between "DA-5209 Tab" and "Lixiana Tab"
Phase 1 trial testing DA-5209 60mg Tab in Healthy in 121 participants. Completed in 4 February 2021.
4 February 2021
Quick facts
| Lead sponsor | Dong-A ST Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 121 |
| Start date | 23 November 2020 |
| Primary completion | 4 February 2021 |
| Estimated completion | 4 February 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- DA-5209 60mg Tab — full drug profile →
- DA-5209 60mg Tab — full drug profile →
- Lixiana 60mg Tab — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Dong-A ST Co., Ltd. — full company profile →
Who can join
19 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An Open-Label, Randomized, 6-sequence, 3-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "DA-5209 60mg Tab" and "Lixiana 60mg Tab" 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 NCT04671316
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Dong-A ST Co., Ltd. trials
Trials by the same sponsor.
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- NCT07027982 — A Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjec · Phase 1 · completed
- NCT07046715 — Clinical Trial Comparing Single-administration of DA-5222 and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 · Phase 1 · completed
- NCT07007533 — A Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy A · 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 NCT04671316 (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 Dong-A ST Co., Ltd.
- Last refreshed: 9 February 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/NCT04671316.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing