Drug Interaction Study Between Dorzagliatin and Empagliflozin

Conditions

• Patients

Eligibility Criteria

Sex

ALL

Age

30 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin — DRUG
  Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration
• Dorzagliatin — DRUG
  Glucokinase activator currently under development

Study Details

This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will be studied.

Key Dates

Start date

Apr 18, 2019

Status verified

Dec 2018

Primary completion

Mar 15, 2020

Completion

Mar 15, 2020

Study Design

Enrollment

16 participants (actual)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Sequential arm ABC
  A: Empagliflozin 25 mg QD in the morning on Days 1-5; B: Empagliflozin 25 mg in the morning and Dorzagliatin 75 mg BID (morning and evening) on Days 6-10, with only the morning dose on Day 10; C: Dorzagliatin 75 mg BID (morning and evening) on Days 11-15, with only the morning dose on Day 15.

Primary Outcome Measure

GMR for Cmax of empagliflozin [ Time Frame: up to 10 days ]

Locations (1)

Find similar trials in Hackensack, NJ

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