Bioequivalence Study of 40 mg Olmesartan Medoxomil (Olmevel) Film Coated Tablets Produced by Pt. Novell Pharmaceutical Laboratories in Comparison with Olmetec 40 mg Film Coated Tablets Manufactured by Daiichi Sankyo Europe GmbH, Germany, packed and Released by Pfizer Manufacturing Deutschland GmbH, Germany, Imported by PT. Pfizer Indonesia

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
INA-MS12MM9
Tanggal Input Registry : 05-12-2022

18-01-2022
AUC0-t, AUC0-∞ and Cmax
T1/2 dan Tmax
 
Bioequivalence Study of 40 mg Olmesartan Medoxomil (Olmevel) Film Coated Tablets Produced by Pt. Novell Pharmaceutical Laboratories in Comparison with Olmetec 40 mg Film Coated Tablets Manufactured by Daiichi Sankyo Europe GmbH, Germany, packed and Released by Pfizer Manufacturing Deutschland GmbH, Germany, Imported by PT. Pfizer Indonesia
Bioequivalence Study of 40 mg Olmesartan Medoxomil (Olmevel) Film Coated Tablets Produced by Pt. Novell Pharmaceutical Laboratories in Comparison with Olmetec 40 mg Film Coated Tablets Manufactured by Daiichi Sankyo Europe GmbH, Germany, packed and Released by Pfizer Manufacturing Deutschland GmbH, Germany, Imported by PT. Pfizer Indonesia
Eksperimental
The reference drug was the market available Olmetec® 40 mg Film Coated Tablets batch number DY4208; manufacturing date March 2020; expiration date February 2022. The test drug was Olmevel® 40 mg film coated caplet produced by PT Novell Pharmaceutical Laboratories, batch number D20H03 manufacturing date August 2020; expiration date August 2022. In the sampling day, each subject received a single oral dose of 40 mg olmesartan medoxomil, either as test or reference formulation administered along with 220 mL of water. The dose was taken 1t 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:

- gave a written informed consent - Healthy subjects, both sexes age between 18 to 55 years old - weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2) - 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) - Acceptable medical history and physical examination - Normal hematology value : hemaglobin, hematocrit, erythrocyte, leucocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR) - Normal laboratory test : sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine - Normal urinalysis results including : color, clarity, specific gravity, pH, Leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sedimants (cells, castc and bacteria). - Normal cardiovascular function proven by electrocardiogram (ECG) result - Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV) negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC) and benzodiazepine. - Negative result for pregnancy test at screening, before period I and before period II of the study - Negative result for rapid antigen test of COVID-19 during COVID-19 pandemic - Female subjects are willing to use contraception during bioequivalence study to prevent pregnancy.

Exclusion Criteria:

- Smoker. If necessary, light smoker (≤ cigarettes/day) can be accepted. - Pregnant woman or nursing mother - Had history of hepatic, cardiovascular, gastrointestinal or renal disease - Had history or condition of biliary obstruction - Potentially sensitive to this type medication or hypersensitive to olmesartan - History of alcohol, drug abuse within 12 moths prior to screening for this study - Received any other medications within fourteen days prior to the start of the study - Participated in any clinical study within 3 months after the date of completion - Donation or loss more than 300 mL og blood within 3 months prior to the screening of the study - Positive result for rapid antigen test of COVID-19 at screening, before starting period I or II.
 
KET-466/UN2.FI/ETIK/PPM.00.02/2021
NA
RG.01.02.321.09.21.00334/UB
CCCII/175/CL/2021
Renny Handayani