A Randomized, Open-label, Multiple Dosing, Crossover Study to Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Empagliflozin 25mg
- Conditions
- Diabetes Mellitus, Type II
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- AUC0-t,ss of Empagliflozin
- Last Updated
- 9 years ago
Overview
Brief Summary
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
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A healthy person whose age is in between 19 to 45 during the screening tests
- •Whose weight is more than 55 kg, BMI is over 18.5 and under 29.9 during the screening test. (BMI (kg/m2) = weight (kg) / {height (m)}2)
- •A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
- •Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening tests
- •The participants must have an ability and willingness to participate throughout the entire trials
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
- •Liver Function Test (AST, ALT) are exceeded over 1.5x the upper limit of the normal range
- •eGFR \< 60mL/min/1.73m2
- •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)
Arms & Interventions
Empagliflozin / Lobeglitazone / Empa.+Lobe.
Period 1: Empagliflozin 25 mg QD for 5 days Period 2: Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days
Intervention: Empagliflozin 25mg
Empagliflozin / Lobeglitazone / Empa.+Lobe.
Period 1: Empagliflozin 25 mg QD for 5 days Period 2: Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days
Intervention: Lobeglitazone 0.5mg
Empagliflozin / Lobeglitazone / Empa.+Lobe.
Period 1: Empagliflozin 25 mg QD for 5 days Period 2: Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days
Intervention: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empagliflozin / Empa.+Lobe. / Lobeglitazone
Period 1: Empagliflozin 25 mg QD for 5 days Period 2: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 3: Lobeglitazone 0.5 mg QD for 5 days
Intervention: Empagliflozin 25mg
Empagliflozin / Empa.+Lobe. / Lobeglitazone
Period 1: Empagliflozin 25 mg QD for 5 days Period 2: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 3: Lobeglitazone 0.5 mg QD for 5 days
Intervention: Lobeglitazone 0.5mg
Empagliflozin / Empa.+Lobe. / Lobeglitazone
Period 1: Empagliflozin 25 mg QD for 5 days Period 2: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 3: Lobeglitazone 0.5 mg QD for 5 days
Intervention: Empagliflozin 25mg/Lobeglitazone 0.5mg
Lobeglitazone / Empagliflozin / Empa.+Lobe.
Period 1: Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg QD for 5 days Period 3: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days
Intervention: Empagliflozin 25mg
Lobeglitazone / Empagliflozin / Empa.+Lobe.
Period 1: Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg QD for 5 days Period 3: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days
Intervention: Lobeglitazone 0.5mg
Lobeglitazone / Empagliflozin / Empa.+Lobe.
Period 1: Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg QD for 5 days Period 3: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days
Intervention: Empagliflozin 25mg/Lobeglitazone 0.5mg
Lobeglitazone / Empa.+Lobe. / Empagliflozin
Period 1: Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg QD for 5 days
Intervention: Empagliflozin 25mg
Lobeglitazone / Empa.+Lobe. / Empagliflozin
Period 1: Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg QD for 5 days
Intervention: Lobeglitazone 0.5mg
Lobeglitazone / Empa.+Lobe. / Empagliflozin
Period 1: Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg QD for 5 days
Intervention: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empa.+Lobe. / Empagliflozin / Lobeglitazone
Period 1: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg QD for 5 days Period 3: Lobeglitazone 0.5 mg QD for 5 days
Intervention: Empagliflozin 25mg
Empa.+Lobe. / Empagliflozin / Lobeglitazone
Period 1: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg QD for 5 days Period 3: Lobeglitazone 0.5 mg QD for 5 days
Intervention: Lobeglitazone 0.5mg
Empa.+Lobe. / Empagliflozin / Lobeglitazone
Period 1: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg QD for 5 days Period 3: Lobeglitazone 0.5 mg QD for 5 days
Intervention: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empa.+Lobe. / Lobeglitazone / Empagliflozin
Period 1: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 2: Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg QD for 5 days
Intervention: Empagliflozin 25mg
Empa.+Lobe. / Lobeglitazone / Empagliflozin
Period 1: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 2: Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg QD for 5 days
Intervention: Lobeglitazone 0.5mg
Empa.+Lobe. / Lobeglitazone / Empagliflozin
Period 1: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 2: Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg QD for 5 days
Intervention: Empagliflozin 25mg/Lobeglitazone 0.5mg
Outcomes
Primary Outcomes
AUC0-t,ss of Empagliflozin
Time Frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
AUC0-t,ss of Lobeglitazone
Time Frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
Cmax,ss of Lobeglitazone
Time Frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
Cmax,ss of Empagliflozin
Time Frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
Secondary Outcomes
- Tmax,ss of Lobeglitazone(Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours)
- t1/2,ss of Lobeglitazone(Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours)
- AUCinf of Lobeglitazone(Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours)
- t1/2,ss of Empagliflozin(Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours)
- Tmax,ss of Empagliflozin(Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours)
- AUCinf of Empagliflozin(Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours)