Bioequivalence Study of Triphasic Oral Contraceptive of Levonorgestrel and Ethinyl Estradiol Sugar-Coated Tablet Manufactured by PT. Sunthi Sepuri (Trinordiol-28®) in Comparison with Triquilar® ED Sugar-Coated Tablet Manufactured in Germany for Bayer Australia Ltd.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-PYY2EYF
Tanggal Input Registry : 01-12-2023

09-09-2022
Cmax, AUCt
 
Bioequivalence Study of Triphasic Oral Contraceptive of Levonorgestrel and Ethinyl Estradiol Sugar-Coated Tablet Manufactured by PT. Sunthi Sepuri (Trinordiol-28®) in Comparison with Triquilar® ED Sugar-Coated Tablet Manufactured in Germany for Bayer Australia Ltd.
Bioequivalence Study of Triphasic Oral Contraceptive of Levonorgestrel and Ethinyl Estradiol Sugar-Coated Tablet Manufactured by PT. Sunthi Sepuri (Trinordiol-28®) in Comparison with Triquilar® ED Sugar-Coated Tablet Manufactured in Germany for Bayer Australia Ltd.
Interventional
Trinordiol-28®
64
 

Inclusion Criteria:

had read the subject information and signed informed consent documents, age range from 18 – 55 years, body mass index between 18 – 25 kg/m2, had a normal electrocardiogram, had the blood pressure within normal range (systolic 90 - 120 mmHg and diastolic 60 - 80 mmHg), had the heart rate within normal range (60 – 100 bpm), had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, passed hormone screening related to LNG and EE

Exclusion Criteria:

those who were pregnant and/or nursing condition, those with a history of hypersensitivity to LNG or EE, or other oral contraceptives 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 pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular or cerebrovascular disease, those who had history or presence of venous/arterial thromboembolism or its risks (diabetes mellitus, severe hypertension, severe dyslipoproteinaemia) or any coagulation disorder or clinically significant hematology abnormalities, those who had history of migraine, those who had history or presence of liver tumours, those who had history or presence of breast cancer, those who current used of any hormonal contraceptives medications (pills at least within 3 months and injectables at least within 1 year prior to screening for this study), those who using any medication (prescription 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 3 months prior to the study (< 90 days), those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study, smoker, those who had history of travelling to another city within the last 14 days without following health authority regulation, those who had history of direct contact with a COVID-19 positive person in the subject’s neighborhood, those who had history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days, those who were positive to SARS CoV-2 antigen test, those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential), 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-318/UN2.F1/ETIK/PPM.00.02/2021
Not applicable
PPUK/PPUB number
519/STD/PML/2019
Nabila Mudin Sutanto