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

Phase 1

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: CKD-387; Drug: D635

• Registration Number: NCT03849339
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-28
• Status Verified: 2019-02
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Primary Completion: 2019-02-21
• Study First Posted: 2019-02-21
• Last Update Posted: 2019-02-21
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 1	CKD-387	* Period 1: D635 * Period 2: CKD-387
Group 1	D635	* Period 1: D635 * Period 2: CKD-387
Group 2	CKD-387	* Period 1: CKD-387 * Period 2: D635
Group 2	D635	* Period 1: CKD-387 * Period 2: D635

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of