A Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-348

Hypertension and Dyslipidemia Clinical Trial

Official title:

An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587206
• Other study ID #: A86_06BE2007
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2020
• Est. completion date: January 15, 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 evaluate the Pharmacokinetics and Tolerability of CKD-348

Description:

A Phase 1 Clinical Trial to evaluate the tolerability and pharmacokinetics in healthy adult volunteers after administration of CKD-348 and co-administration of CKD-828, D097, D337.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 15, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy adult volunteers aged = 19 years

2. Weight =50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2

3. Those who meet the blood pressure criteria during screening tests:

A. Systolic Blood Pressure: 90 to 139 mmHg B. Diastolic Blood Pressure: 60 to 89 mmHg

4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.

5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.

6. Those who agree to contraception during the participation of clinical trial

7. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.

2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.

3. Those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month.

4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.

5. Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol:

Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day

6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.

7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.

8. Those who are deemed insufficient to participate in this clinical study by investigators.

9. Woman who are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension and Dyslipidemia

Intervention

Drug:
• CKD-348
QD, PO
• CKD-828, D097, D337
QD, PO

Locations

Country	Name	City	State
Korea, Republic of	H Plus Yangji Hospital	Seoul	Gwanak-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	AUCt of CKD-348	AUCt: Area under the concentration-time curve from time zero to time	[Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
Primary	Cmax of CKD-348	Cmax: Maximum plasma concentration of the drug	[Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
Secondary	AUCinf of CKD-348	AUCinf: Area under the concentration-time curve from zero up to 8	[Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
Secondary	Tmax of CKD-348	Tmax: Time to maximum plasma concentration	[Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
Secondary	T1/2 of CKD-348	T1/2: Terminal elimination half-life	[Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
Secondary	AUCt/AUCinf of CKD-348	AUCt/AUCinf	[Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]