ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02854748
Recruitment Status : Unknown
Verified August 2016 by Chong Kun Dang Pharmaceutical.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type II Drug: Empagliflozin 25mg Drug: Lobeglitazone 0.5mg Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multiple Dosing, Crossover Study to Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin in Healthy Male Volunteers
Study Start Date : August 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: 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
Drug: Empagliflozin 25mg
Empagliflozin 25 mg QD for 5 days

Drug: Lobeglitazone 0.5mg
Lobeglitazone 0.5mg QD for 5 days

Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days

Experimental: 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
Drug: Empagliflozin 25mg
Empagliflozin 25 mg QD for 5 days

Drug: Lobeglitazone 0.5mg
Lobeglitazone 0.5mg QD for 5 days

Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days

Experimental: 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
Drug: Empagliflozin 25mg
Empagliflozin 25 mg QD for 5 days

Drug: Lobeglitazone 0.5mg
Lobeglitazone 0.5mg QD for 5 days

Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days

Experimental: 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
Drug: Empagliflozin 25mg
Empagliflozin 25 mg QD for 5 days

Drug: Lobeglitazone 0.5mg
Lobeglitazone 0.5mg QD for 5 days

Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days

Experimental: 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
Drug: Empagliflozin 25mg
Empagliflozin 25 mg QD for 5 days

Drug: Lobeglitazone 0.5mg
Lobeglitazone 0.5mg QD for 5 days

Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days

Experimental: 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
Drug: Empagliflozin 25mg
Empagliflozin 25 mg QD for 5 days

Drug: Lobeglitazone 0.5mg
Lobeglitazone 0.5mg QD for 5 days

Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. Tmax,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 ]
  2. t1/2,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 ]
  3. AUCinf 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 ]
  4. Tmax,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 ]
  5. t1/2,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 ]
  6. AUCinf 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. A healthy person whose age is in between 19 to 45 during the screening tests
  2. 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)
  3. A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
  4. Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening tests
  5. The participants must have an ability and willingness to participate throughout the entire trials

Exclusion Criteria:

  1. 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.
  2. 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)
  3. Who has a history of hypersensitivity reactions to Empagliflozin or Lobeglitazone or similar series or other excipient ingredients (aspirin, fibrate, antibiotics, etc.)
  4. 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.
  5. Who falls under the following results

    1. Liver Function Test (AST, ALT) are exceeded over 1.5x the upper limit of the normal range
    2. eGFR < 60mL/min/1.73m2
  6. 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
  7. Who has history of drug abuses or shows a positive result in the urinary drug screen
  8. 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)
  9. Who took other investigational drugs or bioequivalence drugs within 3 months before the first day of dosing
  10. 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
  11. Who constantly drinks alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) or cannot stop drinking alcohol during the clinical test.
  12. Who smokes more than 10 cigarettes per day within 3 months , or who cannot quit smoking when hospitalized
  13. 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
  14. 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
  15. Not using a reliable contraception, planning a pregnancy during the study
  16. Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders
  17. Person who is not determined unsuitable to participate in this test by the researchers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854748


Locations
Korea, Republic of
Dong A University Hospital
Seo-gu, Busan, Korea, Republic of, 49201
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02854748     History of Changes
Other Study ID Numbers: 19DDI16005
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs