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NCT03512821
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fed Conditions
Phase 1 trial testing Ursodiol 500 MG in Healthy in 77 participants. Completed in 30 November 2017.
30 November 2017
Quick facts
| Lead sponsor | Daewoong Pharmaceutical Co. LTD. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 77 |
| Start date | 1 October 2017 |
| Primary completion | 30 November 2017 |
| Estimated completion | 30 November 2017 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Ursodiol 500 MG — full drug profile →
- Urso Forte 500Mg Tablet — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Daewoong Pharmaceutical Co. LTD. — full company profile →
Who can join
18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions
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 NCT03512821
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT03512808 — A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fasting Conditions · Phase 1 · completed
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Other Daewoong Pharmaceutical Co. LTD. trials
Trials by the same sponsor.
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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 NCT03512821 (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 Daewoong Pharmaceutical Co. LTD.
- Last refreshed: 7 May 2018
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/NCT03512821.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing