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NCT05297929
A Bioequivalence Trial of Irbesartan Tablets（0.15g） in Healthy Chinese Subjects
Phase 1 trial testing Irbesartan Tablet in Irbesartan Tablets (0.15g/Tablet) in 54 participants. Status unknown.
9 April 2022
Quick facts
| Lead sponsor | The Affiliated Hospital of Qingdao University |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 17 February 2022 |
| Primary completion | 9 April 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Irbesartan Tablet
Conditions studied
- Irbesartan Tablets (0.15g/Tablet) — all drugs for Irbesartan Tablets (0.15g/Tablet) →
- Under Fasted Condition — all drugs for Under Fasted Condition →
- Under Fed Condition — all drugs for Under Fed Condition →
- Bioequivalence — all drugs for Bioequivalence →
Sponsor
The Affiliated Hospital of Qingdao University
Who can join
Adults 18 to 45, any sex, with Irbesartan Tablets (0.15g/Tablet) or Under Fasted Condition. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To study the pharmacokinetics of test preparation and reference preparation irbesartan tablets (0.15g/tablet) in a single oral administration in fasting and fed state,respectively, in healthy adult subjects, and to evaluate the bioequivalence of the two preparations
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05297929
- 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 NCT05297929 (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: 28 March 2022
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