Bioequivalence Study of 25 mg Quetiapine (Quetvell®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Seroquel® 25 mg Film Coated Tablets Manufactured by AstraZeneca Pharmaceutical Co. Ltd., China, Imported by PT. AstraZeneca Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-908K2A0F
Tanggal Input Registry : 24-01-2025

10-11-2023
AUC0-t , AUC0-inf , Cmax
tmax, t1/2
 
Bioequivalence Study of 25 mg Quetiapine (Quetvell®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Seroquel® 25 mg Film Coated Tablets Manufactured by AstraZeneca Pharmaceutical Co. Ltd., China, Imported by PT. AstraZeneca Indonesia
Bioequivalence Study of 25 mg Quetiapine (Quetvell®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Seroquel® 25 mg Film Coated Tablets Manufactured by AstraZeneca Pharmaceutical Co. Ltd., China, Imported by PT. AstraZeneca Indonesia
Interventional
Quetiapine (Quetvell) 25 mg Film Coated Tablets manufactured by PT Novell Pharmaceutical Laboratories
26
 

Inclusion Criteria:

1. Gave a written informed consent. 2. Healthy subjects, both sexes, age between 18 to 55 years old. 3. Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2). 4. Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm).* 5. Acceptable medical history and physical examination. 6. Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR).* 7. Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine.* 8. Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria).* 9. Normal cardiovascular function was proven by electrocardiogram (ECG) result. 10. Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 11. Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine. 12. Negative result for pregnancy test (would be done for female subjects at screening and before every period). 13. Subject had either received COVID-19 (Coronavirus) vaccine minimum of first booster or negative result for rapid antigen test of COVID-19 at screening Note: * The clinical investigator might include a subject having value outside the accepted range, if in his/her opinion, these values were not clinically significant

Exclusion Criteria:

1. Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted. 2. Pregnant women or nursing mother. 3. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 4. Had history or condition of suicide-related events.(1,2) 5. Had history or condition of urinary retention, clinically significant prostatic hyperthropy, intestinal obstruction or related conditions, increased intraocular pressure or narrow angle glaucoma.(1,2) 6. Had history or condition of QT prolongation.(1,2) 7. Had history or condition of cardiomyopathy or myocarditis.(1,2) 8. Had history or condition of sleep apnea.(1) 9. Had history or condition of seizure.(1,2) 10. Had history or condition of galactose intolerance, the lapp lactase deficiency or glucose, galactose malabsorption.(1,2) 11. Had history or condition of pneumonia.(1,2) 12. Hypersensitivity to quetiapine or similar medication.(1,2) 13. History of alcohol, drug abuse within 12 months prior to screening for this study. 14. Received any other medications within fourteen days prior to the start of the study. 15. Participated in any clinical study within 3 months after the date of completion. 16. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study. 17. Had symptoms related to COVID-19 (e.g. fever, cough, cold, sore throat, or anosmia) or close contact with COVID-19 patients within fourteen days prior to the start of the study.
 
KET-1401/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com