NCT03849495

Brief Summary

A randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of CKD-370 with D745 in healthy 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
28

participants targeted

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

Timeline
Completed

Started Feb 2019

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

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

Study Start

First participant enrolled

February 19, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
Last Updated

March 12, 2019

Status Verified

February 1, 2019

Enrollment Period

26 days

First QC Date

February 20, 2019

Last Update Submit

March 10, 2019

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • AUClast of Empagliflozin

    Area under the plasma concentration-time curve to last concentration of Empagliflozin

    0 hour ~ 48 hour after drug administration

  • Cmax of Empagliflozin

    Maximum plasma concentration of Empagliflozin

    0 hour ~ 48 hour after drug administration

Secondary Outcomes (5)

  • AUCinf of Empagliflozin

    0 hour ~ 48 hour after drug administration

  • Tmax of Empagliflozin

    0 hour ~ 48 hour after drug administration

  • T1/2 of Empagliflozin

    0 hour ~ 48 hour after drug administration

  • CL/F of Empagliflozin

    0 hour ~ 48 hour after drug administration

  • Vd/F of Empagliflozin

    0 hour ~ 48 hour after drug administration

Study Arms (2)

Group A

EXPERIMENTAL

* Period 1: D745 * Period 2: CKD-370

Drug: CKD-370Drug: D745

Group B

EXPERIMENTAL

* Period 1: CKD-370 * Period 2: D745

Drug: CKD-370Drug: D745

Interventions

CKD-370DRUG

Test drug

Group AGroup B
D745DRUG

Reference drug

Group AGroup B

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, digestive, urinary, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
  • Clinical laboratory test values are outside the accepted normal range at Screening
  • aspartate aminotransferase(AST), alanine aminotransferase(ALT) \> 1.5 times the upper limit of the normal range
  • Total Bilirubin \> 1.5 times the upper limit of the normal range
  • creatine phosphokinase(CPK) \> 1.5 times the upper limit of the normal range
  • estimated Glomerular Filtration Rate(eGFR, MDRD\* formula) \< 60 mL/min/1.73m2 (\*MDRD: Modification of Diet in Renal Disease)
  • Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
  • systolic blood pressure(SBP) ≥ 150 mmHg or \< 90 mmHg, diastolic blood pressure(DBP) \> 100 mmHg or \< 50 mmHg
  • 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 first IP dosing
  • Not eligible to participate for the study at the discretion of Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

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, Ph.D. M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+82-2-2072-1920

Deok Yong Yoon

CONTACT

+82-2-2072-1930dyyoon18@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 20, 2019

First Posted

February 21, 2019

Study Start

February 19, 2019

Primary Completion

March 17, 2019

Study Completion

March 21, 2019

Last Updated

March 12, 2019

Record last verified: 2019-02

Locations

KR(1)