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NCT05225974
A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects
Phase 1 trial testing Liraglutide injection in Therapeutic Equivalency in 32 participants. Completed in 19 August 2021.
30 July 2021
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 | 32 |
| Start date | 16 July 2021 |
| Primary completion | 30 July 2021 |
| Estimated completion | 19 August 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Liraglutide injection — full drug profile →
- Liraglutide injection(Victoza®) — 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, male only, with Therapeutic Equivalency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.
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 NCT05225974
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06201819 — Liraglutide Effectiveness in Preoperative Weight-loss for Bariatric-metabolic Surgery · Phase 4 · completed
- NCT05029076 — Human Bioequivalence Test of Liraglutide Injection · Phase 1 · completed
Other The Affiliated Hospital of Qingdao University 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 NCT05225974 (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: 7 February 2022
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/NCT05225974.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing