The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: CKD-387; Drug: D484

• Registration Number: NCT03738449
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D484 under fed condition in healthy adults.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-13
• Study Start: 2019-01-08
• Primary Completion: 2019-01-18
• Study Completion: 2019-01-24
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	CKD-387	* Period 1: CKD-387 * Period 2: D484
Group 1	CKD-387	* Period 1: D484 * Period 2: CKD-387
Group 1	D484	* Period 1: D484 * Period 2: CKD-387
Group 2	D484	* Period 1: CKD-387 * Period 2: D484

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration of Metformin	0 hour ~ 48 hour after drug administration	Cmax 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	AUClast of Metformin

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of