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NCT05786339
Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects
Phase 1 trial testing Tested Irbesartan Tablet in Therapeutic Equivalency in 68 participants. Completed in 15 May 2019.
16 January 2019
Quick facts
| Lead sponsor | The Affiliated Hospital of Qingdao University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 68 |
| Start date | 17 November 2018 |
| Primary completion | 16 January 2019 |
| Estimated completion | 15 May 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Tested Irbesartan Tablet — full drug profile →
- Reference Irbesartan Tablet — full drug profile →
Conditions studied
- Therapeutic Equivalency — all drugs for Therapeutic Equivalency →
Sponsor
The Affiliated Hospital of Qingdao University
Who can join
18 and older, any sex, with Therapeutic Equivalency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The bioavailability of Irbesartan (150 mg) developed by Shenzhen Haibin Pharmaceutical Co., Ltd. was compared with that of reference Irbesartan (Aprovel ®,150 mg) produced by Sanofi Clir SNC. The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy subjects under fasting and 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 NCT05786339
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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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 NCT05786339 (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 The Affiliated Hospital of Qingdao University
- Last refreshed: 27 March 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/NCT05786339.
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