HDDO-1801 Intervention Trial

NCT04097951 | Unknown Phase 1

• 1 other identifier: HT-012-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic Assessment

  Montelukast and Bepotastine Maximum Plasma Concentration

  0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours

• Pharmacokinetic Assessment

  Montelukast and Bepotastine Area under Curve from time zero to the last quantifiable concentration

  0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours

Secondary Outcomes (3)

• Pharmacokinetic Assessment

  0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours

• Pharmacokinetic Assessment

  0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours

• Pharmacokinetic Assessment

  0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours

Study Arms (3)

Montelukast

EXPERIMENTAL

Drug: Combinations

Bepotastine

EXPERIMENTAL

Drug: Combinations

Montelukast + Bepotastine

EXPERIMENTAL

Drug: Combinations

Interventions

Combinations DRUG

Montelukast and Bepotastine Combination

Bepotastine; Montelukast; Montelukast + Bepotastine

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Those who smoke continuously (more than 10 days) or who cannot quit smoking during the clinical trial period.
• Those who participated in other clinical or biological equivalence tests within six months prior to the date of the first medication (the last day of the medication for clinical or biological equivalence tests)
• A person who donated all blood within 60 days prior to the date of the first medication, or who donated the ingredients within 30 days, or who received the blood within 30 days.
• Those who have taken any prescription or herbal medicine within 14 days prior to the date of the first dose or who have taken any general medication (OTC) within 7 days (however, they may participate in a clinical trial if other conditions are reasonable according to the judgment of the tester.)
• A person who has taken a medication that induces and inhibits the drug metabolic enzyme, such as barbital drugs, within one month before the start of the test

Sponsors & Collaborators

• Hyundai Pharmaceutical Co., LTD.: lead

Study Sites (1)

Inha University Hospital

Junggu, Incheon, 22332, South Korea

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Cho Sang Heon

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Son Su Min

CONTACT

82-2-2600-7628; smson@myhdpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 20, 2019
• Study Start: November 8, 2019
• Primary Completion: January 8, 2020
• Study Completion: February 28, 2020
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)