None listed
Conditions
Interventions
Drug : On the first day of the main phase, the subjects are administered one capsule of atomoxin 80mg and one tablet of Dongwha Ditropan 5mg orally once with 150 mL of water.
Sponsors
Chonnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with obstructive sleep apnea who are 19 years of age or older and 75 years of age or younger at the time of screening 2) Those who have clinical symptoms* within 6 months before the first scheduled administration of investigational products and have a score of 5 or more and less than 30 points as a result of the polysomnography at the same institution as the clinical trial organization * Accompanied by clinical symptoms means that symptoms such as excessive daytime sleepiness or cognitive decline for more than 3 months based on screening, or a history of stable hypertension, ischemic heart disease, or stroke. 3) A person who is determined suitable for testing as a result of screening (e.g., vital signs, clinical laboratory tests, 12-lead electrocardiogram, etc.) conducted by principal investigator in charge of testing (or delegated sub-investigators) within 180 days before the first scheduled administration of investigational products 4) A person whose body weight is less than or equal to 90.0 kg at the time of screening and whose body mass index (BMI) is less than or equal to 29.9 kg/m2 A. BMI (kg/m2) = Weight (kg) / {Height (m)}2 5) Upon hearing and fully understanding the detailed description of this clinical trial, the person who voluntarily decides to participate and agrees to comply with the precautions
Exclusion criteria
Exclusion criteria: 1) A person who has the following medical history or symptoms determined by the principal investigator (or delegated sub-investigators) that the medical history or symptoms are likely to interfere with the clinical trial - Hypersensitivity to the ingredients of investigational products (including atomoxetine hydrochloride, oxybutinine hydrochloride, or drugs containing the same family of ingredients) or other drugs - Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption - Deficit lower urinary obstruction symptoms such as dysuria, urinary retention, prostate hypertrophy, hyperthyroidism, autonomic neuropathy, severe gastrointestinal motility disorders, reflux esophagitis, hot air hernia, Parkinson's disease, glaucoma (such as angina glaucoma) or shallow anterior chamber, paralyzed bowel obstruction, severe heart disease (collapsing heart failure, arrhythmia) or vascular disease (corrhotic artery patient), macrocystic colitis patient, chromophilic celloma, facial deformity (such as live-shaped ceiling and small jaw) - A history of having or corresponding to a mental illness (such as mood disorder, obsessive compulsive disorder, etc.) - sleep illnesses such as insomnia - A person who has a history of suicidal behavior and/or continuous suicidal ideation - a person with a history of seizures - Cardiovascular disease requiring additional intervention in addition to standard treatment - a person diagnosed with a stroke within a year 2) A person who has a history of administration of the following drugs or is currently administered, and whose testing the principal investigator (or delegated sub-investigators) determines that the drug is likely to interfere with the clinical trial - Drugs known to interact with investigational products or drugs of the corresponding family(e.g., MAO inhibitors, CYP2D6 inhibitors, salbutamol, drugs that cause QT prolongation, drugs that lower the threshold of seizures, hypertension drugs and blood pressure boosters, tricyclic antidepressants, pseudoephedrine, phenylephedrine, anticholinergic drugs, phenothiazine drugs, amantidine, butyporenone, L-dopa, digitalis) 3) A person who has a diagnostic record of the following medical history and hypersensitivity reactions, etc. determines that the medical history and hypersensitivity reactions are likely to interfere with the clinical trial by the principal investigator (or delegated sub-investigators) - Alcohol abuse or dependence within one year prior to the scheduled administration date of investigational products - Drug abuse or dependence within one year prior to the scheduled administration date of investigational products 4) A person who is finally determined by the principal investigator (or delegated sub-investigators) as a clinically significant result in a screening test (including a retest) with one or more of the following - Symptoms of uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg) - A person who is positive in a serum test (HIV Ab, HBs Ag, HCV Ab) - Those with AST/ALT/Total bilirubin more than 2 times the upper limit - Those with an eGRF less than 60 mL/min/1.73 m2 calculated by CKD EPI 5) a person who can't sleep in a lying position 6) A person who has taken drug metabolism enzyme induction and inhibition drugs, such as barbitals, within one month before the scheduled date of first administration of investigation products 7) A person who has pa
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Vital sign;12-lead ECG;clinical laboratory examination;physical examination;adverse event | — |
Primary
| Measure | Time frame |
|---|---|
| Apnea Hypopnea Index;Nadir SpO2;CT90 (Cumulative Time with oxygen saturation below 90%) | — |
Countries
Korea, Republic of
Contacts
Public ContactGaeun Kang
Chonnam National University Hospital
Outcome results
None listed