Respiratory DiseasePhase 1NCT04097951
HDDO-1801 Intervention Trial
A Phase 1 study testing Combinations in people with Respiratory Disease, run by Hyundai Pharmaceutical Co., LTD. at 1 site in South Korea.
Trial summary
A randomized, open-label, single-dose, 3-period, 6-sequence, 3-way crossover study Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Combinations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Nov 2019to 28 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 21Show fewer
- 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
- mentally ill and drug addicts
- A person who has been on a diet (especially grapefruit juice or its products) that can affect the absorption, distribution, metabolism, and excretion of a drug within seven days prior to the date of the first dose.
- Those who do not agree to exclude the possibility of pregnancy using the medically recognized contraceptives* from the date of the first administration of the clinical trial drug to the date of the last clinical trial medication.
- Medically accepted contraceptives: intrauterine devices, vascular surgery, intubation and block contraception (male condoms, female condoms, cervical caps, contraceptives, sponges, etc.) or when using a combination of two or more blockage methods.
- Those who are unwilling or unable to comply with diet and lifestyle guidelines required for clinical testing;
- Other clinical laboratory tests found that the tester is unfit to participate in a clinical trial due to clinical abnormalities or other reasons (e.g., non-compliance with instructions, non-cooperative attitude, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
A randomized, open-label, single-dose, 3-period, 6-sequence, 3-way crossover study
- Conditions
- Respiratory Disease
- Being tested
- Combinations
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CombinationsDrug
Montelukast and Bepotastine Combination
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Experimental | Not described Receives: Drug: Combinations |
| Bepotastine | Experimental | Not described Receives: Drug: Combinations |
| Montelukast + Bepotastine | Experimental | Not described Receives: Drug: Combinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Assessment
Montelukast and Bepotastine Maximum Plasma Concentration
Measured: 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
Measured: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours
Secondary outcomes (3)
Pharmacokinetic Assessment
Montelukast and Bepotastine Area under Curve from time zero to infinity
Measured: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours
Pharmacokinetic Assessment
Montelukast and Bepotastine time to maximum plasma concentration
Measured: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours
Pharmacokinetic Assessment
Montelukast and Bepotastine half time
Measured: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start8 Nov 2019 (estimated)
- Primary completion8 Jan 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cho Sang Heon, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097951
- Sponsor's protocol ID
- HT-012-01
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04097951
- Acronym / sponsor ID
- HT-012-01
- Conditions
- Respiratory Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2019 (estimated)
- Primary completion
- 8 Jan 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, open-label, single-dose, 3-period, 6-sequence, 3-way crossover study
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Experimental | Drug: Combinations |
| Bepotastine | Experimental | Drug: Combinations |
| Montelukast + Bepotastine | Experimental | Drug: Combinations |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CombinationsMontelukast and Bepotastine Combination | Drug | Bepotastine, Montelukast, Montelukast + Bepotastine |
Primary outcome
Pharmacokinetic Assessment
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours
Montelukast and Bepotastine Maximum Plasma Concentration
Pharmacokinetic Assessment
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours
Montelukast and Bepotastine Area under Curve from time zero to the last quantifiable concentration
3 secondary outcomes
Pharmacokinetic Assessment
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours
Pharmacokinetic Assessment
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours
Pharmacokinetic Assessment
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cho Sang Heon principal investigator
Inha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combinations in people with Respiratory Disease, run by Hyundai Pharmaceutical Co., LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Son Su Min (82-2-2600-7628, smson@myhdpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Assessment (time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.