Healthy Adult Volunteers
Conditions
Brief summary
To compare and evaluate safety and pharmacokinetic Characteristics after administration of ATB-101 or co-administration of ATB-1011 and ATB-1012 in fasted Healthy Adult Volunteers
Detailed description
Pharmacokinetic endpoints 1. Primary endpoint : AUCt, Cmax of Dapagliflozin, Olmesartan 2. Secondary endpoint : AUC∞, Tmax, t1/2, CL/F, Vd/F of Dapagliflozin, Olmesartan Safety evaluation 1. Adverse reactions (but only in case of TEAE) 2. Concomitant drugs 3. Vital signs 4. Laboratory test
Interventions
DRUGATB-101, ATB-1011, ATB-1012
1. Test drug \- Code name: ATB-101 2. Control drug1 * Code name: ATB-1011 * Active ingredient: Olmesartan 3. Control drug2 * Code name: ATB-1012 * Active ingredient: Dapagliflozin
Sponsors
Autotelicbio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open, Randomization, single oral administration, 2 Intervention group, crossover design
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Those who are over 19 years old at the screening visit * 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 * Those who determined as suitable study subjects by the principal investigator * A person who signs the consent form at will, after hearing and understanding a sufficient explanation of the purpose, contents, characteristics of the investigational product, and expected adverse reactions of this clinical trial
Exclusion criteria
* Those who have a clinically significant disease or have a history of such disease * Those who have a history of gastrointestinal surgery * Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs * Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date. * Those who donated whole blood within 2 months or donated components within 2 weeks, or received a blood transfusion within 1 month of the first administration date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt of Olmesartan | Day1(first stage), Day8(scond stage) | Area under the concentration-time curve |
| Cmax of Olmesartan | Day1(first stage), Day8(scond stage) | Maximum concentration of drug in plasma |
| AUCt of Dapagliflozin | Day1(first stage), Day8(scond stage) | Area under the concentration-time curve |
| Cmax of Dapagliflozin | Day1(first stage), Day8(scond stage) | Maximum concentration of drug in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vd/F of Olmesartan | Day1(first stage), Day8(scond stage) | Apparent volume of distribution after non-intravenous administration |
| AUC∞ of Dapagliflozin | Day1(first stage), Day8(scond stage) | Area under the plasma drug concentration-time curve from time 0 to infinity |
| Tmax of Dapagliflozin | Day1(first stage), Day8(scond stage) | Time to maximum plasma concentration |
| AUC∞ of Olmesartan | Day1(first stage), Day8(scond stage) | Area under the plasma drug concentration-time curve from time 0 to infinity |
| CL/F of Dapagliflozin | Day1(first stage), Day8(scond stage) | Apparent total clearance of the drug from plasma after oral administration |
| Vd/F of Dapagliflozin | Day1(first stage), Day8(scond stage) | Apparent volume of distribution after non-intravenous administration |
| T1/2 of Dapagliflozin | Day1(first stage), Day8(scond stage) | Terminal elimination half-life |
| Tmax of Olmesartan | Day1(first stage), Day8(scond stage) | Time to maximum plasma concentration |
| T1/2 of Olmesartan | Day1(first stage), Day8(scond stage) | Terminal elimination half-life |
| CL/F of Olmesartan | Day1(first stage), Day8(scond stage) | Apparent total clearance of the drug from plasma after oral administration |
Countries
South Korea
Outcome results
None listed