An open-label, randomized, single-dose, 2-sequence, 2-period, cross-over phase 1 study under fed state to evaluate the safety and pharmacokinetics of DKB19003” in healthy adult volunteers
- Conditions
- Not Applicable
- Registration Number
- KCT0006104
- Lead Sponsor
- Dongkoo Bio & Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1) A person who is 19 years of age or older when visiting a screening.
2) A person who weighs more than 50 kg (female 45 kg or more) and has a BMI of more than 18.0 kg/m2 and less than 30.0 kg/m2 during a screening visit;
? BMI (kg/m2) = Weight (kg) / {length (m)}^2
3) A person who does not have clinically meaningful congenital or chronic diseases during a screening visit and does not have any pathological symptoms or findings as a result of an internal examination.
4) A person who is found to be suitable for testing by the test manager (or a delegated doctor) according to the characteristics of the medication, as a result of diagnostic tests and ECG such as haematological tests, blood chemistry tests, serum tests, urine tests, etc.
5) A person who, his/her spouse or partner agrees to exclude the possibility of pregnancy by using medically appropriate contraception* and does not provide sperm or eggs from the date of initial administration of clinical trial medications to 14 days after the date of the last clinical trial medication.
* Contraception: Use a combination of intrauterine devices (IUD), vasectomy, intubation and cut-off contraceptives (male condoms, female condoms, cervical caps, contraceptive diaphragm, sponge, etc.) or use a combination of two or more blocking contraceptives when using a kill agent.
6) A person who has signed a consent form according to his/her free will after hearing and understanding the purpose, contents, characteristics of medicine, and expected adverse reactions.
1) A person who has a history of clinically significant diseases corresponding to digestive systems, cardiovascular systems, endocrine systems, respiratory systems, blood and tumors, infectious diseases, kidney and urinary organisms, mental and nervous systems, musculoskeletal systems, immune systems, otolaryngology, skin systems, and ophthalmology systems.
2) A person who has a history of gastrointestinal surgery (except simple appendectomy or hernia surgery) or has gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis) that can affect the absorption of drugs.
3) A person who has taken a drug that induces and inhibits the drug metabolites such as barbithalation drugs within one month (first date of administration) or takes drugs that may interfere with the test within 10 days (first date of administration) can participate in the test (considering the pharmacokinetic and pharmacological characteristics such as clinical trial drugs and half-life of the medication)
4) A person who participated in other clinical trials or biological equivalence tests within six months before the commencement of the test (first date of administration) and administered medicines for clinical trials.
5) A person who donated whole blood within two months (first date of administration) or donated ingredients within two weeks, or received blood transfusion within one month.
6) A person who falls under the following conditions within one month before the commencement of the test (first date of administration):
· Average alcohol intake of 21 cups/week for men
· Average alcohol intake of 14 cups/week for women
(1 cup = 50mL of soju or 30mL of spirits or 250mL of beer)
· Smoking in excess of 20 cigarettes a day on average
8) If the following:
· Patients with a history of hypersensitivity to the active ingredient or other ingredients of this drug
· Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
9) A person who judges that the principal (or delegated doctor) is not suitable for participation in this clinical trial for reasons other than the above selection and exclusion criteria
10) In the case of female volunteers, those who are suspected of pregnancy or are lactating
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt, Cmax
- Secondary Outcome Measures
Name Time Method Tmax, t1/2(if data is allowed), AUC8(if data is allowed)