None listed
Conditions
Interventions
Drug : Study Design
2 Intervention group, open, single-sequence, multiple oral administration crossover design
Arm Number of subjects First stage Second stage
A 20 subjects ATB-1011 ATB-1011+ ATB-1012
Sponsors
Autotelic bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those who are over 19 years old at the screening visit 2) Those with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 with a weight of 50 kg or more (45 kg or more for women) at the screening visit ? BMI(kg/m2) = weight(kg) / {height(m)}2 3) Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit 4) Those who determined as suitable study subjects by the principal investigator (or a delegated sub-investigator) in result of planned and conducted laboratory tests such as hematology, blood chemistry, serum, and urine tests according to the characteristics of the investigational product.
Exclusion criteria
Exclusion criteria: 1) Those who have a clinically significant disease or have a history of such disease in the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious diseases, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin system and ophthalmic system. 2) Those who have a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases 3) Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs within 1 month of the first administration date, or have taken drugs that may interfere with this clinical trial within 10 days of the first administration date. (However, participation is possible depending on the characteristics of pharmacokinetics and pharmacodynamics such as interactions with investigational products or half-life of concomitant drugs) 4) Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ATB-1011 AUCt,ss, Cmax,ss, ATB-1012 AUCt,ss, Cmax,ss, | — |
Secondary
| Measure | Time frame |
|---|---|
| ATB-1011 Tmax,ss, Cmin,ss, ATB-1012 Tmax,ss, Cmin,ss | — |
Countries
Korea, Republic of
Contacts
Public ContactHyo-jeong seo
Autotelic bio
Outcome results
None listed