Diabete Type 2, Hypertension
Conditions
Brief summary
The goal of this Phase 1 clinical trial is to compare the pharmacokinetics and safety of a fixed-dose combination tablet (ATB-U101) versus co-administration of its individual components in healthy Caucasian adult volunteers. The main questions it aims to answer are: * Is the Cmax of Olmesartan and Dapagliflozin bioequivalent across the three treatment regimens? * Is the AUClast of Olmesartan and Dapagliflozin bioequivalent across the three treatment regimens? Researchers will compare ATB-U101 (fixed-dose combination, 40 mg/10 mg) against two reference co-administrations - ATB-1011+ATB-1012 (Korean-approved Olmetec + Forxiga) and ATB-U1011+ATB-U1012 (US-approved Benicar + Farxiga) - to see if the 90% confidence intervals of the geometric mean ratios for the primary PK parameters fall within the bioequivalence range of 80.00-125.00%. Participants will: * Be admitted to the clinical trial center three times (Days 1, 8, and 15), each separated by a 7-day washout period * Receive a single oral dose of one assigned treatment per period under fasting conditions (minimum 10 hours) with 240 mL of water, in a randomized crossover sequence * Have blood samples collected at up to 18 timepoints per period (up to 48 hours post-dose) for PK analysis * Undergo safety assessments including vital signs, ECG, physical examination, and laboratory tests throughout the study, with a final follow-up visit around Day 21-24
Interventions
DRUGATB-U101
ATB-U101 is a fixed-dose combination tablet containing Olmesartan medoxomil 40 mg and Dapagliflozin 10 mg. A single oral dose will be administered under fasting conditions (minimum 10 hours) with 240 mL of water.
DRUGATB-1011
ATB-1011 (Olmetec, Olmesartan medoxomil 40 mg) and ATB-1012 (Forxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water.
DRUGATB-U1011
ATB-U1011 (Benicar, Olmesartan medoxomil 40 mg) and ATB-U1012 (Farxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water.
DRUGATB-1012
ATB-1011 (Olmetec, Olmesartan medoxomil 40 mg) and ATB-1012 (Forxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water.
DRUGATB-U1012
ATB-U1011 (Benicar, Olmesartan medoxomil 40 mg) and ATB-U1012 (Farxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water.
Sponsors
Autotelicbio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Caucasian adult volunteers aged between 19 and 64 years (inclusive) at the time of screening * Caucasian volunteers: Individuals whose parents and grandparents are European, North American, or Middle Eastern, who were born in Europe, North America, or Western Asia, and whose cumulative residence in countries outside those regions since birth is less than 10 years * Individuals whose weight at screening is between 50.0 kg and 97.0 kg and whose body mass index (BMI) is between 18.0 kg/m2 and 30.0 kg/m2
Exclusion criteria
* Subjects with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption * Subjects who test positive on serologic tests (hepatitis B, hepatitis C, human immunodeficiency virus \[HIV\], or syphilis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of Olmesartan | Pre-dose (0h) through 48 hours post-dose |
| AUClast of Olmesartan | Pre-dose (0h) through 48 hours post-dose |
| Cmax of Dapagliflozin | Pre-dose (0h) through 48 hours post-dose |
| AUClast of Dapagliflzin | Pre-dose (0h) through 48 hours post-dose |
Contacts
CONTACTEunji Byeon
Outcome results
None listed