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NCT03196531
A Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared With Clarityne Tablets
Phase 1 trial testing Loratadine (Xisimin [Test Treatment]) in Healthy in 108 participants. Completed in 31 March 2018.
31 March 2018
Quick facts
| Lead sponsor | Xian-Janssen Pharmaceutical Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 108 |
| Start date | 7 November 2017 |
| Primary completion | 31 March 2018 |
| Estimated completion | 31 March 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
- Loratadine (Xisimin [Test Treatment]) — full drug profile →
- Loratadine (Clarityne [Reference Treatment]) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Xian-Janssen Pharmaceutical Ltd. — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the bioequivalence of Xisimin (loratadine) compared with Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.
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 NCT03196531
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Xian-Janssen Pharmaceutical Ltd. trials
Trials by the same sponsor.
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- NCT06082986 — A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China · completed
- NCT03617016 — Preliminarily Evaluate the Efficacy of Domperidone in Adult Chinese Participants With Functional Dyspepsia · Phase 4 · completed
- NCT03220867 — Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions i · Phase 1 · withdrawn
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 NCT03196531 (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 Xian-Janssen Pharmaceutical Ltd.
- Last refreshed: 13 May 2020
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/NCT03196531.
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