This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetics and safety of CKD-339 in healthy volunteers.
Inclusion Criteria:
Healthy adults between the age of 19 and 55 (inclusive) at the time of screening test.
Subjects with a body mass index(BMI) between 18 and 30 kg/m2(BMI = Weight(kg)/ Height(m)2)
Subjects who do not have clinically meaningful congenital or chronic diseases and who do not have medical examination results (such as electroencephalogram, electrocardiogram, chest and gastroscopy or gastrointestinal radiography, if necessary) during screening visits.
Subjects judged by investigators to be suitable for screening tests based on laboratory tests (e.g., blood tests, urine tests) and ECG, which were conducted according to the characteristics of the IP.
Subjects who voluntarily signed and dated the informed consent form after fully understanding its contents.
Subjects who had agreed to use medically appropriate contraceptive methods* to exclude the possibility of pregnancy from the first dose of the IP to 14 days after the last dose, and not to donate sperm or ovum.
Exclusion Criteria:
Subjects who have taken a drug metabolase-inducing and inhibiting drug such as barbitals within one month prior to the first dosing date or a drug that may interfere with this test within 10 days prior to the first dose of IP.
Subjects who had been administered investigational product from other clinical study or bioequivalence study within the 6 months prior to the first dose of IP.
Subjects who donated whole blood within 8 weeks, or blood components within 2 weeks prior to the first dose of IP.
Subjects who have a history of gastrointestinal resection that may affect the absorption of drugs.
Subjects with a history of regular alcohol consumption meeting any of the following criteria within 1 month prior to the first dose of IP.
Patients with the following conditions
Subjects with a history of psychiatric disorders.
Subjects who are considered unsuitable for participation in this bioequivalence study by the Investigator (or delegated Sub-investigator) for reasons other than the inclusion and exclusion criteria listed above.
Female subjects who are pregnant, suspected of being pregnant, or breastfeeding.
tghong@bumin.co.kr
Period 1: A single oral dose of 2 tablets under fasting condition(D311, D107), Period 2: A single oral dose of 1 tablet under fasting condition(CKD-339)
Period 1: A single oral dose of 1 tablet under fasting condition(CKD-339), Period 2: A single oral dose of 2 tablets under fasting condition(D311, D107)
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