Bioequivalence Study of Clonazepam 2 mg Tablets Manufactured by PT. Sunthi Sepuri in Comparison with Rivotril® 2 mg Tablets Manufactured by Roche Farma S.A., Spain

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-5S6XPK
Tanggal Input Registry : 30-03-2023

04-11-2022
90% Confidence Interval, Cmax and AUCt
N.A
 
Bioequivalence Study of Clonazepam 2 mg Tablets Manufactured by PT. Sunthi Sepuri in Comparison with Rivotril® 2 mg Tablets Manufactured by Roche Farma S.A., Spain
Bioequivalence Study of Clonazepam 2 mg Tablets Manufactured by PT. Sunthi Sepuri in Comparison with Rivotril® 2 mg Tablets Manufactured by Roche Farma S.A., Spain
Interventional
Subjects were given a single dose of 2 mg clonazepam tablet of either formulation (test or reference) with 240 mL of water
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Inclusion Criteria:

All of the included subjects had met these criteria below: 1. Subjects had read the subject information and signed informed consent documents 2. Subjects healthy male and female 3. Subjects age range from 18 – 55 years 4. Subjects’ body mass index between 18 – 25 kg/m2 5. Subjects had a normal electrocardiogram 6. Subjects had the blood pressure within normal range (systolic 90 - 120 mmHg and diastolic 60 - 80 mmHg) 7. Subjects had the heart rate within normal range (60 – 100 bpm) 8. Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. 9. Subjects accepted to use protection (condom) before any intercourse with their spouse throughout the study until 7 days after the last drug administration

Exclusion Criteria:

This bioequivalence study was not eligible for: 1. Those who were pregnant and/or nursing condition 2. Those with a history of contraindication or hypersensitivity to clonazepam or other benzodiazepines or other ingredients in the study products, or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction 3. 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 surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease 4. Those with history or presence of any coagulation disorder or clinically significant hematology abnormalities. 5. Those who had history or presence of any severe respiratory insufficiency 6. Those who had history or presence of any sleep apnea syndrome 7. Those who had history or presence of any myasthenia gravis 8. Those who had history or presence of any narrow angle glaucoma 9. 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, within two weeks prior to the drug administration day 10. Those who had participated in any clinical study within 3 months prior to the study (< 90 days) 11. Those who had donated or lost 300 mL (or more) of blood within 3 months prior to the study 12. Smoker subject who smoked more than 10 cigarettes a day 13. Those who had history of travelling to another city within the last 14 days without following health authority regulation 14. Those who had of direct contact with a COVID-19 positive person in the subject’s neighborhood within 3 days prior to screening 15. Those who had history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days 16. Those who was positive to SARS-CoV-2 antigen test 17. Those who was positive to HIV, HBsAg, and HCV tests (to be kept confidential) 18. Those who had history of drug or alcohol abuse within 12 months prior to screening for this study 19. Those who was unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-1223/UN2.F1/ETIK/PPM.00.02/2021
552/STD/PML/2021
Nabila Sutanto