None listed
Conditions
Interventions
Drug : Single oral administration of reference drug(Vivantzheng 20 milligrams) under fasting conditions and single oral dose of test drug(VIVIANT TAB.20 mg) under fasting conditions 14 days apart. Or
Sponsors
Huons
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A healthy adult who is aged 19 years or over at the time of medical examination or a woman over 35 years of age who has proven menopausal menopause • 12 months after the final menstrual period • Volunteers whose serum FSH (follicle stimulating hormone) is above the menopausal level (BMI: body weight (kg) / {height (m)} 2) with a body weight of 50.0 kg or more and an obesity index BMI of 18.0 to 30.0 kg / 3) If there is no congenital or chronic disease requiring treatment, the result of medical examination (EEG, electrocardiogram, chest and endoscopy or gastrointestinal radiological examination if necessary) 4) It is suitable for clinical laboratory examination and physical examination (physical examination) such as serum test, hematology test, blood chemistry test, urine test, and vital signs and 12-lead electrocardiogram Judged person 5) After hearing the detailed explanation of the test and understanding it fully, he / she has agreed to voluntarily decide to participate and to obey the notice.
Exclusion criteria
Exclusion criteria: 1) Patients with clinically significant liver / biliary system, kidney, nervous system, respiratory system, endocrine system, digestive system, blood / tumor, urinary system, cardiovascular system, musculoskeletal system, mental disease or allergy disease, Volunteer ? • Patients with severe renal impairment ? • Patients with liver dysfunction ? • Hypertriglyceridemia ? • Patients with venous thromboembolism (deep-vein thrombosis, pulmonary embolism, retinal vein thrombosis, etc.) ? • Patients with unexplained uterine bleeding ? • Patients with symptoms or signs of endometrial cancer ? • Breast cancer patients 2) Those who have a history of hypersensitivity reaction to the major component or constituents of the bioequivalence test drug or other clinically significant drugs or additives 3) Patients with rare genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder 4) A person with a history of gastrointestinal disorders (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs 5) Drugs for bioequivalence testing Drugs that have been known to significantly induce drug metabolizing enzymes (eg, barbiturate) or inhibit them within 30 days of the first dose 6) Food supplements that may affect the absorption, distribution, metabolism and excretion of drugs, abnormal diets that may affect drug metabolism 7) In clinical laboratory tests for liver function evaluation, AST, ALT, ALP, ?-GTP and T. bilirubin were more than twice the upper limit of normal range 8) If Creatinine exceeds the upper limit of normal range or eGFR calculated by the Modification of Diet in Renal Disease (MDRD) is less than 60mL / min / 1.73m2 9) There is a history of regular alcohol consumption exceeding 210 g / week within the first 6 months of the first dose, and a person who can not abstain from the 48 hours before the first dose (250 ml of beer (5%)) = 10 g, soju (20%) 1 cup (50 ml) = 8 g, wine (12%) 1 cup (125 ml) = 12 g) 10) Smokers with an average daily smoking amount exceeding 10 cigarettes per day for the past 3 months, and those who can not quit smoking 48 hours before each dose 11) A person who has taken any prescribed medicines or herbal medicines within 2 weeks of the first medicament's day, or has taken any general medicines (OTC) or vitamin medicines within 1 week (provided that the medicinal / pharmacological / If there is no effect on the biological characteristics, the participant may participate in the bioequivalence test at the discretion of the experimenter. 12) Persons who have participated in bioequivalence studies or other clinical trials within 3 months of the first day of administration, provided that the criteria for termination of participation in other clinical trials and bioequivalence studies are based on the last day of administration. 13) Whole blood donation within 2 months before the first administration day, Component blood donation within 1 month, Transfusion within 1 month before the first administration day 14) Those who have ingested grapefruit (grapefruit) or have not been able to consume it during the entire bioequivalence study 48 hours before the first dose 15) Those who can not consume or consume caffeine-containing foods (coffee, tea, cola, etc.) during the period from 24 hours before discharge to discharge at each time 16)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf | — |
Countries
Korea, Republic of
Contacts
Public ContactYeun sun
Chungnam National University
Outcome results
None listed