drugset / Trial / NCT04572685
Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
Phase 1
Completed
36 enrolled
Luye Pharma Group Ltd.
Alliance for Clinical Trials in Oncology · collabEvolution Research Group · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients and to compare the PK of LY03010 P1 and P2 with that of INVEGA SUSTENNA® following a single IM injection of 156 mg dosage level.
Timeline
- Start
- 2020-01-22
- Primary completion
- 2020-06-26
- Completion
- 2020-08-20
Outcome
Met primary endpoint
release “LY03010在 美 国 开 展 的 关 键 临 床 试 验 已 完 成 并 达 到 预 期 终 点” luye.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | paliperidone palmitate | Unknown | 156 mg | Intramuscular |