NCT03848637

Brief Summary

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_1 type-2-diabetes-mellitus

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

February 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 14, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

10 days

First QC Date

February 19, 2019

Last Update Submit

March 4, 2019

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

  • Maximum plasma concentration of Empagliflozin

    Cmax of Empagliflozin

    Time Frame: 0 hour ~ 48 hour after drug administration

  • Maximum plasma concentration of Metformin

    Cmax of Metformin

    Time Frame: 0 hour ~ 48 hour after drug administration

  • Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration

    AUClast of Empagliflozin

    Time Frame: 0 hour ~ 48 hour after drug administration

  • Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration

    AUClast of Metformin

    Time Frame: 0 hour ~ 48 hour after drug administration

Secondary Outcomes (10)

  • Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity

    0 hour ~ 48 hour after drug administration

  • Area under the plasma concentration of Metformin-time curve from time zero to infinity

    0 hour ~ 48 hour after drug administration

  • Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration

    0 hour ~ 48 hour after drug administration

  • Time to reach maximum (peak) plasma concentration of Metformin following drug administration

    0 hour ~ 48 hour after drug administration

  • Half-life of Empagliflozin

    0 hour ~ 48 hour after drug administration

  • +5 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

* Period 1: D387 (reference drug) * Period 2: CKD-387 (test drug)

Drug: CKD-375Drug: D387

Group 2

EXPERIMENTAL

* Period 1: CKD-387 (test drug) * Period 2: D387 (reference drug)

Drug: CKD-375Drug: D387

Interventions

CKD-375DRUG

Test drug

Group 1Group 2
D387DRUG

Reference drug

Group 1Group 2

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 19 to 55 years
  • Females who are not pregnant or breastfeeding or who have surgical infertility
  • Signed informed consent form

You may not qualify if:

  • History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
  • Clinical laboratory test values are outside the accepted normal range at Screening
  • Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.
  • Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge.
  • Participated in a clinical trial within 90 days prior to 1st IP dosing
  • Not eligible to participate for the study at the discretion of Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kyung-Sang Yu, M.D., Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung-Sang Yu, M.D.,Ph.D

CONTACT

+82-2-2072-1920

Soyoung Lee, Pharmacist

CONTACT

+82-2-740-8872sylee0829@snu.ac.kr

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

February 19, 2019

First Posted

February 21, 2019

Study Start

April 14, 2019

Primary Completion

April 24, 2019

Study Completion

May 1, 2019

Last Updated

March 6, 2019

Record last verified: 2019-03