Bioequivalence Study of 75 mg Oseltamivir Capsule Produced by Pt. Novell Pharmaceutical Laboratories in Comparison with Tamiflu® 75 mg Capsule Manufactured by Cenexi SAS, France, For F. Hoffmann-La Roche Ltd., Switzerland, Importad by PT. Boehringer Ingelheim Indonesia.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
INA-OR87W37
Tanggal Input Registry : 10-01-2023

30-08-2021
The primary ovjective of this study was to establish the buoequivalence of 75 mg Oseltamivir Capsule Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Tamiflu® 75 mg Capsule Manufactured by Cenexi SAS, France, For F. Hoffmann-La Roche Ltd., Switzerland, Importad by PT. Boehringer Ingelheim Indonesia, distributed by PT. Roche Indonesia.
Tolerance assessment was not a major objective in this study. However, comparison of tolerance between the two products was a secondary objective. Ther criteria of safety would include any adverse reactions of significant abnormal laboratory values, or abnormal physical examinations or vital signs measurements recorded during the study. Any other observations were documented in the subject's Case Report Form (CRF).
 
Bioequivalence Study of 75 mg Oseltamivir Capsule Produced by Pt. Novell Pharmaceutical Laboratories in Comparison with Tamiflu® 75 mg Capsule Manufactured by Cenexi SAS, France, For F. Hoffmann-La Roche Ltd., Switzerland, Importad by PT. Boehringer Ingelheim Indonesia.
Bioequivalence Study of 75 mg Oseltamivir Capsule Produced by Pt. Novell Pharmaceutical Laboratories in Comparison with Tamiflu® 75 mg Capsule Manufactured by Cenexi SAS, France, For F. Hoffmann-La Roche Ltd., Switzerland, Importad by PT. Boehringer Ingelheim Indonesia.
Eksperimental
The reference drug was the market available Tamiflu® 75 mg Capsule batch number F0259B01; manufacturing date October 2019; expiration date October 2023. The test drug was Oseltamivir® 75 mg Capsule produced by PT Novell Pharmaceutical Laboratories, batch number D21D30 manufacturing date May 2021; expiration date May 2023. In the sampling day, each subject received a single oral dose of 75 mg Oseltamivir, 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:

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, ureum, creatinine 8. Normal urinalysis results including : color, clarity, specific gravity, pH, Leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sedimants (cells, castc 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:

1. Smoker. If necessary, light smoker (≤ cigarettes/day) can be accepted. 2. Pregnant woman or nursing mother 3. Had history of hepatic, cardiovascular, gastrointestinal or renal disease 4. Potentially sensitive to this type medication or hypersensitive to oseltamivir phosphate or to any component of the product 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 og 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-754/UN2.FI/ETIK/PPM.00.02/2021
CCCX/207/CL/2021
registrasinpl@novellpharm.com