Bioequivalence study of clozapine 25 mg tablet produced by PT Dexa Medica in comparison with the comparator drug (Leponex® 25 mg Tablet produced by Mylan Hungary Kft., Hungary licensed by Viatris Healthcare GmbH, Germany) when administered as a 12.5 mg dose under fasting condition in healthy subjects

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-2W2837E
Tanggal Input Registry : 07-02-2024

04-09-2023
To find out whether the bioavailability of clozapine 25 mg tablet produced by PT Dexa Medica is equivalent to that of the comparator drug (Leponex® 25 mg Tablet produced by Mylan Hungary Kft., Hungary licensed by Viatris Healthcare GmbH, Germany) when administered as a 12.5 mg dose under fasting condition in healthy subjects.
 
Bioequivalence study of clozapine 25 mg tablet produced by PT Dexa Medica in comparison with the comparator drug (Leponex® 25 mg Tablet produced by Mylan Hungary Kft., Hungary licensed by Viatris Healthcare GmbH, Germany) when administered as a 12.5 mg dose under fasting condition in healthy subjects
Bioequivalence study of clozapine 25 mg tablet produced by PT Dexa Medica in comparison with the comparator drug (Leponex® 25 mg Tablet produced by Mylan Hungary Kft., Hungary licensed by Viatris Healthcare GmbH, Germany) when administered as a 12.5 mg dose under fasting condition in healthy subjects
Interventional
Test drug: Clozapine 25 mg Tablet (produced by PT Dexa Medica, Indonesia) Reference drug: Leponex® 25 mg Tablet produced by Mylan Hungary Kft., Hungary licensed by Viatris Healthcare GmbH, Germany
24
 

Inclusion Criteria:

1. Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study. 2. Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during the screening and could be considered healthy based on the evaluation. 3. Aged 18 - 55 years inclusive. 4. Non-smokers. 5. Body mass index within 18 to 25 kg/m2. 6. Vital signs (after 10 minutes rest) must be within the following range: a) Systolic blood pressure : 110 - 129 mmHg. b) Diastolic blood pressure : 70 - 84 mmHg. c) Pulse rate : 60 - 90 bpm 7. Willing to practice abstention or contraception during the study.

Exclusion Criteria:

1. History of allergy or hypersensitivity or contraindication to clozapine or allied drugs. 2. Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug). 3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness. 4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc. 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. 6. Clinically significant hematology abnormalities. 7. Clinically significant electrocardiogram (ECG) abnormalities. 8. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. 9. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiophatic Parkinson’s disease. 10. Past history of anaphylaxis or angioedema. 11. History of seizure, epilepsy or any kind of neurological disorders. 12. History of drug or alcohol abuse within 12 months prior to screening for this study. 13. Participation in any clinical trial within the past 90 days calculated from the last visit until this study’s first dosing day. 14. History of any bleeding or coagulative disorders. 15. Presence of difficulty in accessibility of veins in left or right arm during screening. 16. A donation or significant blood loss within 90 days before this study’s first dosing day. 17. Intake of any prescription (especially clozapine), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
 
: KET-911/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Kartika Widyanty