Bioequivalence Study of Tamoxifen 20 mg Tablets Manufactured by PT Global Onkolab Farma in Comparison with Novaldex® 20 mg Tablets Manufactured by AstraZeneca UK Ltd., United Kingdom.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-OPW2DR2
Tanggal Input Registry : 27-05-2024

27-12-2023
Cmax, AUCt
 
Bioequivalence Study of Tamoxifen 20 mg Tablets Manufactured by PT Global Onkolab Farma in Comparison with Novaldex® 20 mg Tablets Manufactured by AstraZeneca UK Ltd., United Kingdom.
Bioequivalence Study of Tamoxifen 20 mg Tablets Manufactured by PT Global Onkolab Farma in Comparison with Novaldex® 20 mg Tablets Manufactured by AstraZeneca UK Ltd., United Kingdom.
Interventional
Tamoxifen 20 mg tablets
14
 

Inclusion Criteria:

subject had read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures, Healthy male, Age ranges from 18 – 55 years, Body mass index between 18 – 25 kg/m2, Had a normal electrocardiogram, Had resting vital signs (after 10 – 15 minutes of resting) were within the following ranges, systolic blood pressure: 90 – 129 mmHg, diastolic blood pressure: 60 – 84 mmHg and Pulse/Heart rate: 60 – 100 beats per minute, had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

those with a history of hypersensitivity or contraindication to tamoxifen or allied drugs or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction, those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric/intestine surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease, those who had history of stroke, deep venous thrombosis, or pulmonary embolism, those who had history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who disagreed to use protection (condom) during intercourse with their spouse throughout the study (until the last day of blood sampling), those who were using any medication (prescription such as erythromycin, cyclosporine, nifedipine, and diltiazem; or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day, those who had participated in any clinical study within the past 90 days prior to the study,those who had donated or lost 300 mL (or more) of blood within 3 months prior to the study, those who was smoker, those who had history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days, those who had history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea with in the last 14 days, those who were positive result for HIV, HbsAg, and HCV tests, Those who had history of drug or alcohol abuse within 12 months prior to screening for this study,those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-954/UN2.F1/ETIK/PPM.00.02/2019
Not applicable
PPUK/PPUB number
483/STD/PML/2019
Nabila Mudin S