A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

Hypertension Clinical Trial

Official title:

A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety/Tolerability According to Formulations of CKD-386 in Healthy Male Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03920579
• Other study ID #: 183PK18034
• Status: Recruiting
• Phase: Phase 1
• Start date: April 1, 2019
• Est. completion date: May 2019

Study information

• Verified date: April 2019
• Source: Chong Kun Dang Pharmaceutical
• Contact: Dongseong Shin, M.D, Ph.D
• Phone: +82-32-460-9459
• Email: dsshin[@]gilhospital.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Description:

A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy volunteers aged between =20 and =45 years old

2. Weight = 50 kg, with calculated body mass index(BMI) of = 18.5 and = 27.0 kg/m2

3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings

4. Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests

5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

1. History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug

2. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption

3. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
• CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
• D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

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	AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013	AUC0-t: Area under the concentration-time curve from time zero to time	0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Primary	Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013	Cmax: Maximum plasma concentration of the drug	0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Secondary	AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013	AUCinf: Area under the concentration-time curve from zero up to 8	0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31
Secondary	Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013	Tmax: Time to maximum plasma concentration	0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Secondary	t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013	t1/2: Terminal elimination half-life	0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Secondary	CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013	CL/F: Apparent total body clearance of the drug	0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Secondary	Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013	Vd/F: Apparent volume of distribution	0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Secondary	AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013	AUC0-t: Area under the concentration-time curve from time zero to time	0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Secondary	Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013	Cmax: Maximum plasma concentration of the drug	0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31