Bioequivalence Study of 20 mg Omeprazole Delayed Release Capsules Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Losec 20 mg Capsules Marketed by AstraZeneca Limited, New Zealand.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
INA-P33PZRL
Tanggal Input Registry : 18-01-2023

16-03-2022
It was concluded that the Omeprazole 20 mg delayed release capsules produced by PT Etercon Pharma for PT. Novell Pharmaceutical Laboratories was bioequivalent to the comparator drug (Losec® 20 mg capsules marketed by AstraZeneca Limited, New Zealand), based on the findings that the 90% confidence intervals of the ratio AUC0-t, AUC0-∞ and Cmax parameters were within the limits of 80.00 - 125.00%.
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Bioequivalence Study of 20 mg Omeprazole Delayed Release Capsules Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Losec 20 mg Capsules Marketed by AstraZeneca Limited, New Zealand.
Bioequivalence Study of 20 mg Omeprazole Delayed Release Capsules Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Losec 20 mg Capsules Marketed by AstraZeneca Limited, New Zealand.
Eksperimental
The reference drug was Losec® 20 mg capsules marketed by AstraZeneca Limited, New Zealand and the test drug was Omeprazole 20 mg delayed release capsules produced by PT Etercon Pharma for PT Novell Pharmaceutical Laboratories. On the sampling day, each subject received a single oral dose of 20 mg Omeprazole, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose.
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Inclusion Criteria:

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 < 140 mmHg and > 90 mmHg, diastolic blood pressure < 90 mmHg and > 60 mmHg) and heart rate (60-90 bpm) 5. Acceptable medical history and physical examination 6. Normal hematology value : hemaglobin, hematocrit, erythrocyte, leucocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR) 7. Normal laboratory test : sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, urine, 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 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 at screening, before period I and before period II of the study 13. Negative result for rapid antigen test of COVID-19 during COVID-19 pandemic

Exclusion Criteria:

Exclusion Criteria 1. Smoker. If necessary, light smoker (≤ 5 cigarettes/day) can be accepted. 2. Pregnant woman or nursing mother 3. Had history of hepatic, cardiovascular, gastrointestinal or renal disease 4. Potentially hypersensitive to omeprazole or substitute benzimidazoles. 5. History of alcohol, drug abuse within 12 moths prior to screening for this study 6. Received any other medications within fourteen days prior to the start of the study 7. Participated in any clinical study within 3 months after the date of completion 8. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study 9. Positive result for rapid antigen test of COVID-19 at screening, before starting period I or II.
 
KET-232/UN2.F1/ETIK/PPM.00.02/2021
N/A
Persetujuan Protokol Uji Bioekivalensi Nomor : RG.01.02.321.03.22.00724/UB
CCLXXVII/183/CL/2020
Nurul Kartika