Bioequivalence Study of Clozapine (½ x 25 mg) Tablets Manufactured by PT Kimia Farma Tbk in Comparison with Leponex® (½ x 25 mg) Tablets Manufactured by Mylan Healthcare GmbH, Lȕtticher Straβe 5, 53842 Troisdorf, Germany.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-3EOS2E2
Tanggal Input Registry : 09-12-2024

20-02-2024
Cmax and AUCt
 
Bioequivalence Study of Clozapine (½ x 25 mg) Tablets Manufactured by PT Kimia Farma Tbk in Comparison with Leponex® (½ x 25 mg) Tablets Manufactured by Mylan Healthcare GmbH, Lȕtticher Straβe 5, 53842 Troisdorf, Germany.
Bioequivalence Study of Clozapine (½ x 25 mg) Tablets Manufactured by PT Kimia Farma Tbk in Comparison with Leponex® (½ x 25 mg) Tablets Manufactured by Mylan Healthcare GmbH, Lȕtticher Straβe 5, 53842 Troisdorf, Germany.
Interventional
Clozapine (½ x 25 mg) tablets
24
 

Inclusion Criteria:

Subjects had read the subject information and were able to give written informed consent for participation in the study and comply with the study protocol/procedures, Subjects were healthy male and female, Subjects’ age ranges from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following ranges : Systolic blood pressure: 110 – 129 mmHg, Diastolic blood pressure: 70 – 84 mmHg, Pulse/Heart rate: 60 – 100 beats per minute, Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

those who were pregnant and/or nursing condition, those with a history of hypersensitivity or contraindication to clozapine or allied drugs or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction, those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric/intestine surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease (myocarditis), those who had history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who had history of epilepsy or seizures, those who had history of significant orthostatic hypotension or multiple syncopal episodes, those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug (inhibitors or inducers of CYP3A4 or CYP1A2) and contraindicated to the study drug, within one week prior to the drug administration day, those who participate in any clinical study within the past 90 days prior to the study, those who had donate or lost 300 mL (or more) of blood within 3 months prior to the study, those who were smoker those who had not received the complete primary SARS CoV-2 vaccine, those who was positive result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine), those who had history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days, those with a had history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days, those who were positive result for HIV, HbsAg, and HCV tests (to be kept confidential), those who had history of drug or alcohol abuse within 12 months prior to screening for this study, those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-1328/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
752/STD/PML/2023
Nabila Mudin S