NCT02854748

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

1 month

First QC Date

August 1, 2016

Last Update Submit

August 7, 2016

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (4)

  • AUC0-t,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

  • Cmax,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

  • AUC0-t,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

  • Cmax,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

Secondary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (6)

Empagliflozin / Lobeglitazone / Empa.+Lobe.

EXPERIMENTAL

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 25mgDrug: Lobeglitazone 0.5mgDrug: Empagliflozin 25mg/Lobeglitazone 0.5mg

Empagliflozin / Empa.+Lobe. / Lobeglitazone

EXPERIMENTAL

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 25mgDrug: Lobeglitazone 0.5mgDrug: Empagliflozin 25mg/Lobeglitazone 0.5mg

Lobeglitazone / Empagliflozin / Empa.+Lobe.

EXPERIMENTAL

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 25mgDrug: Lobeglitazone 0.5mgDrug: Empagliflozin 25mg/Lobeglitazone 0.5mg

Lobeglitazone / Empa.+Lobe. / Empagliflozin

EXPERIMENTAL

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 25mgDrug: Lobeglitazone 0.5mgDrug: Empagliflozin 25mg/Lobeglitazone 0.5mg

Empa.+Lobe. / Empagliflozin / Lobeglitazone

EXPERIMENTAL

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 25mgDrug: Lobeglitazone 0.5mgDrug: Empagliflozin 25mg/Lobeglitazone 0.5mg

Empa.+Lobe. / Lobeglitazone / Empagliflozin

EXPERIMENTAL

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 25mgDrug: Lobeglitazone 0.5mgDrug: Empagliflozin 25mg/Lobeglitazone 0.5mg

Interventions

Empagliflozin 25mgDRUG

Empagliflozin 25 mg QD for 5 days

Empa.+Lobe. / Empagliflozin / LobeglitazoneEmpa.+Lobe. / Lobeglitazone / EmpagliflozinEmpagliflozin / Empa.+Lobe. / LobeglitazoneEmpagliflozin / Lobeglitazone / Empa.+Lobe.Lobeglitazone / Empa.+Lobe. / EmpagliflozinLobeglitazone / Empagliflozin / Empa.+Lobe.
Lobeglitazone 0.5mgDRUG

Lobeglitazone 0.5mg QD for 5 days

Empa.+Lobe. / Empagliflozin / LobeglitazoneEmpa.+Lobe. / Lobeglitazone / EmpagliflozinEmpagliflozin / Empa.+Lobe. / LobeglitazoneEmpagliflozin / Lobeglitazone / Empa.+Lobe.Lobeglitazone / Empa.+Lobe. / EmpagliflozinLobeglitazone / Empagliflozin / Empa.+Lobe.
Empagliflozin 25mg/Lobeglitazone 0.5mgDRUG

Empagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days

Empa.+Lobe. / Empagliflozin / LobeglitazoneEmpa.+Lobe. / Lobeglitazone / EmpagliflozinEmpagliflozin / Empa.+Lobe. / LobeglitazoneEmpagliflozin / Lobeglitazone / Empa.+Lobe.Lobeglitazone / Empa.+Lobe. / EmpagliflozinLobeglitazone / Empagliflozin / Empa.+Lobe.

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dong A University Hospital

Seo-gu, Busan, 49201, South Korea

Location

Related Publications (1)

  • Kim YK, Hwang JG, Park MK. No Relevant Pharmacokinetic Drug-Drug Interaction Between the Sodium-Glucose Co-Transporter-2 Inhibitor Empagliflozin and Lobeglitazone, a Peroxisome Proliferator-Activated Receptor-gamma Agonist, in Healthy Subjects. Drug Des Devel Ther. 2021 Apr 28;15:1725-1734. doi: 10.2147/DDDT.S302215. eCollection 2021.

    PMID: 33953542DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozinlobeglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 3, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

KR(1)