Phase 1 study to evaluate the safety and pharmacokinetics comparison of AD-104 in healthy adult volunteers

Not Applicable

Completed

Conditions: Endocrine, nutritional and metabolic diseases

Registration Number: KCT0009332

Lead Sponsor: Addpharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1) A person who is 19 years of age or older at the time of a screening visit
2) A person who has no birth or chronic disease based on screening and has no medical examination results (e.g., electrocardiogram, chest and gastroscopy or gastrointestinal radiography if necessary) or no pathological symptoms or findings
3) 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, etc.) established and conducted by a person in charge of testing (or a delegated doctor in charge of testing) according to the characteristics of investigational product.
4) those with the following blood pressure
·Systolic blood pressure not less than 90 mmHg but not more than 139 mmHg
·The diastolic blood pressure is greater than or equal to 60 mmHg and less than or equal to 89 mmHg
5) Those whose BMI measurement results are greater than or equal to 18Kg/m2 and less than or equal to 30Kg/m2 at the time of a screening visit
·BMI (Kg/m2) = Weight (Kg) / Height (m)2
6) Those who have no history of gastrointestinal diseases or gastrointestinal resection that can affect the absorption of clinical trial drugs
7) A person who has no history of mental illness within five years prior to the date of the screening visit
8) In the case of a female test subject, a person who is confirmed not to be pregnant at the time of a medical examination
9) A person who has signed a consent form according to his/her free will after hearing and understanding the purpose, contents, characteristics of the drug, expected adverse reactions, etc. of this test

Exclusion Criteria

1) A person who has taken a drug metabolite-inducing and inhibiting drug, such as barbiturant drugs, within one month before the start of the test (the first administration date)
2) Drug users who are likely to interfere with the test within 10 days before the start of the test (the first day of administration)
3) Excessive alcohol drinkers within one month prior to the date of the screening visit
·More than 14 cups/week for women
·More than 21 cups/week for men
(1 glass = 50mL of soju or 30mL of spirits or 250mL of beer)
4) A person who has participated in other clinical trials or biological equivalence tests within six months prior to the implementation of the relevant test (the date of first administration)
5) A person who has donated whole blood or donated ingredients within two weeks before the start of the test (the first date of administration), or received a blood transfusion within one month
6) A person who is not qualified for participation in this clinical trial by a person in charge of the trial (or a delegated test doctor)
7) Those whose blood AST (GOT) or ALT (GPT) levels exceed twice the upper limit of the reference range or whose ?-GTP levels exceed 1.5 times the upper limit of the reference range
8) a person with a liver disorder
9) People with moderate to severe renal impairment (serum creatinine level greater than 2.5 mg/dL)
10) A person who is hypersensitive to this drug and its components
11) Those with pre-existing gallbladder disease
12) Those who have experienced photoallergy or phototoxicity during treatment with fibrate or ketoprofen
13) A person with bile duct cirrhosis
14) Those with pancreatitis (excluding acute pancreatitis caused by severe hypertriglyceridemia)
15) A lactating women
16) A person who does not agree to medically exclude the possibility of pregnancy by using contraception* by himself, 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 (IUD, IUS), vasectomy, oviduct ligation and blocking contraception (male condom, female condom, cervical cap, contraceptive septum, sponge, etc.), or use a combination of two or more blocking contraception when using a fertilizer