Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin

Sponsor
Chong Kun Dang Pharmaceutical
Study ID
NCT02854748
Phase
PHASE1
Status
Unknown

Conditions

  • Diabetes Mellitus, Type II

Eligibility Criteria

Sex
MALE
Age
19 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Aug 31, 2016
Status verified
Aug 2016
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Primary Outcome Measure

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 ]