Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 Under Fed Condition

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 Under Fed Condition in Healthy Adults

The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 under fed condition in healthy adults.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: CKD-387; Drug: D635

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults aged 19 to 55 years
2. Females must be menopause or surgical infertility
3. Signed informed consent form
4. Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

1. History of clinically significant hepatic, renal, nervous, immune, respiratory, 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) > 1.25 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. Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
4. Participated in a clinical trial within 90 days prior to 1st IP dosing
5. Not eligible to participate for the study at the discretion of Investigator
6. Other exclusive inclusion criteria, as defined in the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Period 1: D635; Period 2: CKD-387	Drug: CKD-387; Test drug; Drug: D635; Reference drug
Experimental: Group 2; Period 1: CKD-387; Period 2: D635	Drug: CKD-387; Test drug; Drug: D635; Reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Metformin	Maximum plasma concentration of Metformin	0 hour ~ 48 hour after drug administration
AUClast of Metformin	Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration	0 hour ~ 48 hour after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf of Metformin	Area under the plasma concentration of Metformin-time curve from time zero to infinity	0 hour ~ 48 hour after drug administration
Tmax of Metformin	Time to reach maximum (peak) plasma concentration of Metformin following drug administration	0 hour ~ 48 hour after drug administration
t1/2 of Metformin	Half-life of Metformin	0 hour ~ 48 hour after drug administration
CL/F of Metformin	Apparent clearance of Metformin	0 hour ~ 48 hour after drug administration
Vd/F of Metformin	Apparent volume of distribution of Metformin	0 hour ~ 48 hour after drug administration

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Anticipated): February 21, 2019
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 184BE18028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No