Bioequivalence Study of 8 mg Ondansetron Film Coated Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Zofran® 8 mg Film Coated Tablets Manufactured by Aspen Bad Oldesloe GmbH, Germany, Registered and Imported by Novartis Corporation Sdn. Bhd., Malaysia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-9HRFORP
Tanggal Input Registry : 11-12-2024

22-04-2024
AUC0-t , AUC0-∞ , Cmax
Tmax
 
Bioequivalence Study of 8 mg Ondansetron Film Coated Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Zofran® 8 mg Film Coated Tablets Manufactured by Aspen Bad Oldesloe GmbH, Germany, Registered and Imported by Novartis Corporation Sdn. Bhd., Malaysia
Bioequivalence Study of 8 mg Ondansetron Film Coated Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Zofran® 8 mg Film Coated Tablets Manufactured by Aspen Bad Oldesloe GmbH, Germany, Registered and Imported by Novartis Corporation Sdn. Bhd., Malaysia
Interventional
Ondansetron 8 mg FCT manufactured by PT Novell Pharmaceutical Laboratories
22
 

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 (was done for female subjects at screening, before period I and before period II of the study). 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 congenital long QT syndrome.(1,2) 5. Had or might develop prolongation of QTc due to electrolyte abnormalities, congestive heart failure, or bradyarrhythmias.(1,2) 6. Had history or condition of gastrointestinal obstruction.(1,2) 7. Hypersensitivity to ondansetron or similar medication.(1,2) 8. History of alcohol, drug abuse within 12 months prior to screening for this study. 9. Received any other medications within fourteen days prior to the start of the study. 10. Participated in any clinical study within 3 months after the date of completion. 11. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study.
 
KET-127/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com