KCT0003839
Completed
未知
A phase 1 clinical trial to evaluate the safety and pharmacokinetic characteristics after administration of fixed-dose combination or loose combination of HUG186 in healthy adult male or menopausal female volunteers
Huons0 sites52 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Huons
- Enrollment
- 52
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Men who are healthy adults aged 19 years or over at the time of screening or women who are over 35 years old and whose menopausal symptoms have been proven through gynecological examination
- •\- 12 months after the final menstrual period
- •\- Volunteers whose serum FSH (follicle stimulating hormone) is above the menopausal level
- •2\) Those with a body weight of 50\.0 kg or more and a body mass index (BMI) of 18\.5 kg / m2 to 30\.0 kg / m2
- •\* BMI \= body weight (kg) / {height (m)} 2
- •3\) Patients without congenital or chronic diseases requiring medical treatment and no medical symptoms or symptoms
- •4\) Clinical laboratory tests and vital signs such as serum test, hematology test, blood chemistry test, blood coagulation test, urine test, urine drug test, and 12\-lead electrocardiogram test were performed according to the characteristics of the drug during the screening test. A person determined to be suitable for
- •5\) Those who agree to apply sunscreen when exposed to sunlight for more than 1 hour.
- •6\) Other foods with high vitamin content, including vitamin D, foods with enhanced vitamin content, and those who have agreed to prohibit consumption of vitamin D supplements
- •7\) Having heard and fully understood the details of this clinical trial and agreed in writing to voluntarily participate in the study and agreed to keep the subject compliance during the clinical trial
Exclusion Criteria
- •1\) A volunteer with clinically significant liver, kidney, nervous system, respiratory, digestive, endocrine, hematologic, urographic, cardiovascular, musculoskeletal or mental illnesses,
- •? venous thromboembolism (deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, etc.)
- •? Patients with hypertriglyceridemia
- •? Patients with renal disease, patients with renal stone, patients with renal failure
- •? Patients with liver disorder
- •? hypercalcium patients, sarcoidosis
- •? and calcium urine patients
- •? patients with unexplained uterine bleeding
- •? Patients with symptoms or signs of endometrial cancer
- •? People with vitamin D deficiency
Outcomes
Primary Outcomes
Not specified
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