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NCT04328506
Bioequivalency Study of CM082 Tablet in Healthy Volunteers
Phase 1 trial testing CM082 tablet (test product) in Advanced Malignant Solid Tumors in 96 participants. Completed in 27 July 2020.
27 July 2020
Quick facts
| Lead sponsor | AnewPharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 1 June 2020 |
| Primary completion | 27 July 2020 |
| Estimated completion | 27 July 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- CM082 tablet (test product) — full drug profile →
- CM082 tablet (reference product) — full drug profile →
Conditions studied
- Advanced Malignant Solid Tumors — all drugs for Advanced Malignant Solid Tumors →
Sponsor
AnewPharma — full company profile →
Who can join
Adults 18 to 45, any sex, with Advanced Malignant Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.
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 NCT04328506
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Malignant Solid Tumors
Currently open trials in the same condition.
- NCT07292402 — JSKN022 in Subjects With Advanced Malignant Solid Tumors · Phase 1 · recruiting
- NCT06717750 — A Study of CSCJC3456 in Patients With Advanced Malignant Tumors · Phase 1 · recruiting
- NCT06728189 — A Clinical Research About CD70-targeted CAR-NKT Cells Therapy in Subjects with Advanced Malignant Solid Tumors · Phase 1 · recruiting
- NCT06499350 — A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06571422 — Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors · Phase 1 · recruiting
Other AnewPharma trials
Trials by the same sponsor.
- NCT04434326 — The Absorption, Metabolism and Excretion of [14C]CM082 in Human · Phase 1 · completed
- NCT04126668 — A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers · Phase 1 · completed
- NCT04222842 — CM082 in Patients With Myopic Choroidal Neovascularization (CNV) · Phase 1 · suspended
- NCT03904719 — CM082 and JS001 in Patients With Advanced Small-cell Lung Cancer (SCLC) · Phase 2 · unknown
- NCT03710863 — Safety and Tolerability of Oral CM082 in Patients With wAMD · Phase 2 · unknown
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 NCT04328506 (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 AnewPharma
- Last refreshed: 26 November 2021
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/NCT04328506.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing