A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Drug-drug Interactions Between DHP2306R1 and DHP2306R2 in Healthy Adult Volunteers
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Drug-drug Interactions Between DHP2306R1 and DHP2306R2 in Healthy Adult Volunteers
This phase 1 study is to evaluate the safety and pharmacokinetic drug interactions of DHP2306R1 and DHP2306R2 when administered alone and in combination in healthy conditions.
Participants will be taken DHP2306R1 and DHP2306R2 alone or combination for 3 period, randomized in six-sequence.
Inclusion Criteria:
Exclusion Criteria:
1) Current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history. Those who have
① Renal impairment
② Liver disorder
2) For women, pregnant women (Urine-HCG positive) or lactating women
3) Persons with a history of hypersensitivity or clinically significant hypersensitivity to DHP2306R1, DHP2306R2, or components of clinical investigational drugs, aspirin, non-steroidal anti-inflammatory drugs (including COX-2 inhibitors), or sulfonamide drugs.
4) People with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
5) Those with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs
6) At the time of screening, those with clinically significant findings including the following findings on 12-lead electrocardiography
7) At the time of screening, a person who shows the following results in clinical laboratory tests
8) If you have a history of drug abuse or test positive for drugs of abuse in a urine drug test
9) At the time of screening, those who showed vital signs measured in a sitting position after resting for more than 3 minutes include systolic blood pressure ≥ 150 mmHg or ≤ 90 mmHg, diastolic blood pressure ≥ 100 mmHg or ≤ 60 mmHg, and pulse ≤ 40 bpm or ≥ 100 bpm.
10) Persons who administered drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month before the first administration date
11) People who eat abnormal diets that may affect the absorption, distribution, metabolism, and excretion of investigational drugs or who consume foods that may affect drug metabolism
12) Any prescription drugs or herbal preparations that may affect the characteristics of investigational drugs, including cyclosporine, were administered within 2 weeks before the first administration date, or any over-the-counter drugs (OTC drugs) or vitamin preparations were administered within 10 days. (However, if the drug does not affect the pharmacokinetic properties of the clinical trial drug, the applicant may participate in the clinical trial at the discretion of the investigator.)
13) Those who participated in and received treatment in another clinical trial within 6 months prior to the date of first administration (however, the end standard for participation in other clinical trials is based on the date of last administration, and the next day is calculated as 1 day)
14) Those who have donated whole blood within 2 months before the first administration date or component blood donation within 1 month, received a blood transfusion within 1 month, or cannot refrain from donating blood from the time of written consent to the time of PSV
15) Those who have continuously drank alcohol (exceeding 21 units/week, 1 unit=10 g=12.5 mL of pure alcohol) within 6 months before the first administration date or who are unable to abstain from drinking from the time of written consent to the time of PSV
16) Smokers who smoked more than 10 cigarettes on average per day within 3 months before the first administration date and those who were unable to quit smoking from 24 hours before the first administration to the time of the last blood collection in each period
17) Those who consumed food containing grapefruit (grapefruit) from 48 hours before the first administration until the time of PSV or who cannot refrain from consuming it
18) Those who consumed or were unable to refrain from consuming caffeine-containing foods (coffee, green tea, black tea, carbonated drinks, coffee milk, tonic drinks, etc.) during the period from 24 hours before the first administration in each period until the last blood collection.
19) Those who engaged in vigorous exercise exceeding the level of daily life during the period from 48 hours before the first administration to the time of PSV, or who cannot refrain from vigorous exercise
20) From the time of written consent until 2 weeks after the last date of administration of the investigational drug, even if you, your spouse, or partner are planning to become pregnant or are not planning to become pregnant, you must use reliable contraceptive methods (e.g., administration of contraceptives and implantation or intrauterine device, sterilization procedure ( Those who are not using vasectomy, tubal ligation, etc.) or barrier methods (combined use of spermicides, condoms, contraceptive diaphragms, vaginal sponges, or cervical caps))
21) Persons judged by the investigator to be unsuitable for participation in clinical trials due to reasons other than the above selection/exclusion criteria