Last reviewed · How we verify
NCT05468645
In Vivo Mass Balance Study of [14C]Hemay005
Phase 1 trial testing [14C]Hemay005 in Health Volunteer in 6 participants. Completed in 1 September 2022.
1 September 2022
Quick facts
| Lead sponsor | Ganzhou Hemay Pharmaceutical Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 6 |
| Start date | 25 July 2022 |
| Primary completion | 1 September 2022 |
| Estimated completion | 1 September 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- [14C]Hemay005 — full drug profile →
Conditions studied
- Health Volunteer — all drugs for Health Volunteer →
Sponsor
Ganzhou Hemay Pharmaceutical Co., Ltd — full company profile →
Who can join
Adults 18 to 40, male only, with Health Volunteer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a single-center, single-dose, non-randomized, open-label study to evaluate the in vivo mass balance of \[14C\]Hemay005. Six healthy male subjects are planned to be enrolled.
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 NCT05468645
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Health Volunteer
Currently open trials in the same condition.
- NCT05256719 — Clinical Study of Recombinant Humanized CTLA-4-FC Fusion Protein Injection in Healthy Subjects · Phase 1 · recruiting
Other Ganzhou Hemay Pharmaceutical Co., Ltd trials
Trials by the same sponsor.
- NCT07314242 — A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD · Phase 2 · not yet recruiting
- NCT06610890 — Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets · Phase 1 · completed
- NCT06610903 — Bioequivalence Test of Hemay005 Tablets · Phase 1 · completed
- NCT06380153 — To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment · Phase 1 · completed
- NCT06376474 — To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage · Phase 1 · recruiting
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 NCT05468645 (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 Ganzhou Hemay Pharmaceutical Co., Ltd
- Last refreshed: 29 February 2024
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/NCT05468645.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing