Trials / Completed
CompletedNCT04849026
Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18
A Randomized, Open Label, Multiple-dose, 2-way Crossover, Phase I Study to Compare the Safety and Pharmacokinetics Profile of WID-CLZ18 and Clozaril 100 mg Tablet (Clozapine) After Oral Administration in Schizophrenia Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Whanin Pharmaceutical Company · Industry
- Sex
- All
- Age
- 20 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This clinical study is a randomized, open label, multiple-dose, 2-way crossover, phase I (Bioequivalence) study to compare the safety and pharmacokinetics profile of WID-CLZ18 and Clozaril 100 mg tablet (Clozapine) after oral administration in schizophrenia patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Clozaril 100 mg (Clozapine) | 2 Doses/Day for 10 days |
| DRUG | WID-CLZ18 | 2 Doses/Day for 10 days |
Timeline
- Start date
- 2021-01-15
- Primary completion
- 2022-08-14
- Completion
- 2022-08-14
- First posted
- 2021-04-19
- Last updated
- 2023-05-16
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04849026. Inclusion in this directory is not an endorsement.