Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-19

Study Completion Date

2019-03-21

Brief Summary

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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

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type EXPERIMENTAL

CKD-370

Intervention Type DRUG

Test drug

D745

Intervention Type DRUG

Reference drug

Group B

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

Group Type EXPERIMENTAL

CKD-370

Intervention Type DRUG

Test drug

D745

Intervention Type DRUG

Reference drug

Interventions

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CKD-370

Test drug

Intervention Type DRUG

D745

Reference drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. History of clinically significant hepatic, renal, nervous, immune, respiratory, digestive, urinary, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
2. 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
3. Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.
4. 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.
5. Participated in a clinical trial within 90 days prior to first IP dosing
6. Not eligible to participate for the study at the discretion of Investigator

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes