Status and phase
Conditions
Treatments
About
This study is a randomized, open-label, multiple dosing, crossover study to evaluate the drug-drugs interaction between Lobeglitazone and Empagliflozin in healthy male volunteers
Full description
To healthy male subjects of 30, following treatments are administered dosing in each 3 period(Lobeglitazone or Empagliflozin or Lobe.+Empa.) and wash-out period is a minimum of 7 days.
Test Drug 1: Lobeglitazone 0.5mg 1T
Test Drug 2: Empagliflozin 25mg 1T
Pharmacokinetic blood samples are collected up to 24hrs.
Safety, pharmacokinetic and the drug-drugs interaction are assessed.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
A person who has a history of clinically significant cardiovascular, respiratory, liver, kidney, endocrine system, immune system, urinary system diseases, blood-tumor diseases, mental illness.
Who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy)
Who has a history of hypersensitivity reactions to Empagliflozin or Lobeglitazone or similar series or other excipient ingredients (aspirin, fibrate, antibiotics, etc.)
A person whose electrocardiogram value includes QTc > 450 msec, PR interval > 200 msec, QRS duration > 120 msec after screening, or who show clinically significant opinion.
Who falls under the following results
Who shows the vital sign values of more than 150 mmHg or less than 90 mmHg in systolic pressure or more than 95 mmHg or less than 60 mmHg in diastolic blood pressure
Who has history of drug abuses or shows a positive result in the urinary drug screen
Who took any prescribed drugs, medicinal plants within the 2 weeks before the first day of dosing or takes any over-the-counter drugs or vitamin supplements within 1 week (but, if other conditions are met, they can still participate in the clinical test through the researcher's judgment)
Who took other investigational drugs or bioequivalence drugs within 3 months before the first day of dosing
Who participated in whole blood donation within 2 months before the first of dosing, or platelet donations within 1 months. Who received blood a month before the first day of dosing
Who constantly drinks alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) or cannot stop drinking alcohol during the clinical test.
Who smokes more than 10 cigarettes per day within 3 months , or who cannot quit smoking when hospitalized
Who cannot limit intake of grapefruit or grapefruit containing foods in 48hrs from the first dosing of clinical testing drug to collect pharmacokinetic blood samples
Who absorb caffeinated drinks (coffee, tea (black or green tea), soda, coffee flavored milk, energy drinks, etc.) or cannot stop absorbing them 24 hours before hospitalization until discharging
Not using a reliable contraception, planning a pregnancy during the study
Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders
Person who is not determined unsuitable to participate in this test by the researchers
Primary purpose
Allocation
Interventional model
Masking
30 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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