A Randomized, Open-label, Single-dose Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of HDDO-18011 and HDDO-18012 in Healthy Adult Subjects

Hyundai Pharmaceutical Co., LTD.1 site in 1 country36 target enrollmentNovember 8, 2019

InterventionsCombinations

Overview

A randomized, open-label, single-dose, 3-period, 6-sequence, 3-way crossover study

Registry

clinicaltrials.gov

Start Date

November 8, 2019

End Date

February 28, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Sponsor

Responsible Party

Sponsor

•Healthy adult male aged 19 years and younger than 50 years old at the time of the screening
•Those who weigh more than 50 kg and whose calculated BMI is within the 18.0-29.0 kg/m2 range BMI = (weight \[kg\])/(key \[m\])2
•A person who is judged to be suitable for a test through physical examination and examination according to this test plan. That is, a person who has no congenital or chronic diseases and who has not had any pathological symptoms or findings within the last 3 years
•A person who is judged to be suitable for a test in accordance with this test plan (if the results of a clinical laboratory test are within or outside the reference value of the hospital affiliated with Inha University Medical Center, the tester determines that there is no clinical significance)
•After hearing the detailed description of this clinical trial and fully understanding it, the person who agrees in writing to decide his/her participation and to comply with the precautions

•Persons with clinical significant cardiovascular, respiratory, liver, kidney, nervous system, endocrine, blood and tumor, mental illness, and urinary tract
•Persons with gastrointestinal relationship diseases (such as gastrointestinal ulcers, gastritis, gastrointestinal tract diseases, Crohn's disease, etc.) that may affect the absorption of clinical trial medications, and persons with past history of gastrointestinal relationship surgery (except for simple appendectomy or hernia surgery)
•Those with genetic problems such as galactose intolerance, Lapp lactase deficient or glucose-galactose malabsorption
•A person with a history of hypersensitivity or clinically significant hypersensitivity to a drug or other drug (aspirin, antibiotics, etc.) that contains the components of Montelukast and the components of Bepotastine or the same family.
•A person who showed a clinically significant low blood pressure (hydraulic \< 90mmHg) or high blood pressure (hydraulic ≥ 150mmHg or dilatant blood pressure ≥ 95mmHg) during the screening test
•One of the following results is displayed in a screening test:
•AST or ALT \> Double the normal range limit
•Total bilirubin \> 2.0 mg/dL
•Ratios of sand dune (eGFR) \< 60mL/min/1.73m2
•Drinking continuously (21 units/week exceeded, 1 unit = 10 g = 12.5 mL of pure alcohol) or who cannot abstain from drinking during clinical trials