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

C

Chong Kun Dang

Status and phase

Unknown
Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: CKD-370
Drug: D745

Study type

Interventional

Funder types

Industry

Identifiers

NCT03849495
191BE18033

Details and patient eligibility

About

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

Enrollment

28 estimated patients

Sex

All

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy adults aged 19 to 55 years
  • Females who are not pregnant or breastfeeding or who have surgical infertility
  • Signed informed consent form
  • Other inclusion criteria, as defined in the protocol

Exclusion criteria

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
  • Other exclusive inclusion criteria, as defined in the protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 2 patient groups

Group A
Experimental group
Description:
Period 1: D745 Period 2: CKD-370
Treatment:
Drug: D745
Drug: CKD-370
Group B
Experimental group
Description:
Period 1: CKD-370 Period 2: D745
Treatment:
Drug: D745
Drug: CKD-370

Trial contacts and locations

1

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Central trial contact

Deok Yong Yoon; Kyung Sang Yu, Ph.D. M.D.

Data sourced from clinicaltrials.gov

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