A Study to Investigate the PK and Safety of CKD-393

Type II Diabetes Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-393 and Co-administration of CKD-501, D759 and H053 Under Fed Condition in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768673
• Other study ID #: A98_04BE2022P
• Status: Completed
• Phase: Phase 1
• Start date: March 26, 2021
• Est. completion date: April 27, 2021

Study information

• Verified date: February 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393

Description:

A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393 and co-administration of CKD-501, D759 and H053 under fed condition in healthy adults

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 27, 2021
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

[Inclusion Criteria]

1. Between 19 aged and 50 aged healthy adult

2. Body weight more than 55kg for male, more than 50kg for female

3. Body Mass Index over 18.5kg/m2 and under 27.0kg/m2

4. if female, the subject must satisfy more than one of the following:

• subject who have reached menopause (no natural menstruation for at least 2 years.)
• subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method) [Exclusion Criteria]

1. Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness

2. Subject with one of the following laboratory test results

• AST, ALT > UNLx1.5
• eGRF < 60 ml/min/1.73 m2 (MDRD formula)
• immuno-serology test results in positive
• Systolic blood pressure > 150mmHg or <90mmHg, Diastolic blood pressure >100mmHg or <50mmHg

3. Subject who has history of the following and the history may affect safety of the subject or result of this study

• History of any prescription drug or herbal medicine within 14 days before first administration investigational products
• History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products
• History of drug-metabolizing induction/inhibition enzyme such as barbital

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Drug:
• CKD-393 formulation I
single, oral administration of 2 tablets under fed condition
• CKD-393 formulation II
single, oral administration of 2 tablets under fed condition
• D501, D759, H053
single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Seodaemun-gu,

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum concentration of drug in plasma	0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Primary	AUClast	Area under the plasma drug concentration-time curve to last concentration	0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Secondary	AUCinf	Area under the plasma drug concentration-time curve from 0 to infinity	0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Secondary	Tmax	Time to maximum plasma concentration	0 h (hours)h, 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Secondary	t1/2	Terminal elimination half-life	0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Secondary	Vd/F	Apparent Volume of Distribution	0 h (hours), 0.25 h (hours)h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Secondary	CL/F	Apparent Clearance	0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h