Phase 1 study to evaluate the safety and pharmacokinetics of AD-220 compared to coadministration of AD-220A and AD-220B in healthy adult volunteers
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009254
- Lead Sponsor
- Addpharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1) A person who is 19 years of age or older at the time of a screening visit
2) Those who weigh 50 kg or more (women weigh 45 kg or more) and have a BMI of 18.0 kg/m2 or more and 30.0 kg/m2 or less at screening visits
? BMI (kg/m2) = Weight (kg)/{Height (m)}2
3) A person who has no birth or chronic disease based on screening and has no medical examination results or no pathological symptoms or findings
4) A person who is deemed suitable as a test subject as a result of clinical laboratory tests (hematology tests, blood chemistry tests, serological tests, urine tests, immunoserological tests, etc.) and electrocardiogram tests (EKG) established and conducted by a person in charge of testing (or a delegated doctor in charge of testing) according to the characteristics of clinical trials
5) A person who has agreed to exclude the possibility of pregnancy using medically appropriate contraception* and not to provide sperm or ovum by himself/herself, his/her spouse, or his/her partner from the date of first administration of the clinical trial drug until 14 days after the date of last administration of the clinical trial drug
* Contraception: Use a combination of intrauterine devices, vasectomy, ovarian ligation and blocking contraception (male condoms, female condoms, cervical caps, contraceptive septum, sponges, etc.) or more than one blocking contraception when using a fertilizer
6) A person who has signed a consent form according to his/her free will after hearing and understanding the purpose, contents, characteristics of clinical trial drugs, and expected adverse reactions, etc. of this clinical trial
1) Those who have or have a history of clinically significant diseases corresponding to digestive systems, cardiovascular systems, endocrine systems, respiratory systems, blood and tumors, infectious diseases, kidney and urinary systems, mental and nervous systems, musculoskeletal systems, immune systems, otolaryngological systems, dermatological systems, and ophthalmology
2) A person who has a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of drugs or who has gastrointestinal diseases
3) A person who has taken a drug metabolite-inducing and inhibiting drug such as barbiturant drugs within one month of the first administration date or who has taken a drug that may interfere with this clinical trial within 10 days of the first administration (but can participate in consideration of pharmacokinetics and pharmacodynamics such as interaction with clinical trial drugs and half-life of concomitant drugs)
4) A person who has participated in other clinical trials or biological equivalence trials within six months of the first administration and administered clinical trials
5) A person who has donated whole blood within 8 weeks of the first administration date or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks
6) A person who falls under the following conditions within one month of the first administration date
· For men, the average alcohol consumption exceeds 21 cups/week
· For women, the average alcohol consumption exceeds 14 cups/week
(1 glass = 50 mL of soju or 30 mL of spirits or 250 mL of beer)
· an average of more than 20 cigarettes a day
7) any of the following persons
· Patients with a history of hypersensitivity to the main or component of this drug
· Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
8) a patient with the following conditions
· Patients with active liver disease involving persistent elevated serum transaminase of unknown cause or elevated serum transaminase exceeding three times the upper limit of normal
· a patient with myopathy
· a patient given a combination of cyclosporine
· Patients with moderate renal impairment or severe renal impairment (eGFR <60 ml/min/1.73m2)
· a patient prone to myopathy/rhabdomyolysis
· a patient with hypothyroidism
· a patient with a history of genetic muscular disease or a family history
· Patients with a history of muscle toxicity to statin drugs (HMG-CoA converting enzyme inhibitors) or fibrate drugs
· an alcoholic patient
· a co-administration of fibrate drugs
· Patients with active liver disease or patients with persistent increase in unexplained serum aminotransferase levels
9) A person who determines that the person in charge of the test (or the delegated person in charge of the test) is not suitable for participation in this clinical trial due to reasons other than the above criteria for selection and exclusion
10) In the case of female volunteers, a pregnant woman or a person suspected of pregnancy or lactating women
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method