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NCT05318820
A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers
EARLY_PHASE1 trial testing HMPL-523 in Healthy Subject in 39 participants. Completed in 30 September 2022.
31 July 2022
Quick facts
| Lead sponsor | Hutchison Medipharma Limited |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 39 |
| Start date | 1 June 2022 |
| Primary completion | 31 July 2022 |
| Estimated completion | 30 September 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- HMPL-523 — full drug profile →
Conditions studied
- Healthy Subject — all drugs for Healthy Subject →
Sponsor
Hutchison Medipharma Limited — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Subject. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects.
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 NCT05318820
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HMPL-523
Trials testing the same drug.
- NCT07348133 — Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets · Phase 1 · completed
- NCT05781906 — Human Mass Balance of [14C]HMPL-523 in Healthy Adult Male Chinese Subjects · Phase 1 · completed
- NCT05720767 — HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study · Phase 1 · completed
- NCT05571787 — HMPL-523 Food Effect and Proton Pump Inhibitor Study · Phase 1 · completed
- NCT05029635 — Phase III Study on HMPL-523 for Treatment of ITP · Phase 3 · active not recruiting
Other recruiting trials for Healthy Subject
Currently open trials in the same condition.
- NCT03897270 — Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects · NA · recruiting
- NCT03303846 — Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients · NA · active not recruiting
- NCT03491176 — Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer · active not recruiting
- NCT03207854 — Collection of Immunology Specimens From Patients With Cancer or Blood Disorders, and Healthy Volunteers · recruiting
- NCT03199365 — Tu Salud Si Cuenta Intervention in Increasing Physical Activity and Healthy Eating Among Latino Families · NA · active not recruiting
Other Hutchison Medipharma Limited trials
Trials by the same sponsor.
- NCT05509699 — Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer · Phase 2 · completed
- NCT05277454 — Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT · Phase 1 · unknown
- NCT05015608 — Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification · Phase 3 · active not recruiting
- NCT05029635 — Phase III Study on HMPL-523 for Treatment of ITP · Phase 3 · active not recruiting
- NCT05015621 — A Phase 3 Study to Evaluate Surufatinib Plus Toripalimab in the Treatment of Advanced Neuroendocrine Carcinoma · Phase 3 · 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 NCT05318820 (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 Hutchison Medipharma Limited
- Last refreshed: 25 April 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/NCT05318820.
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