A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(2)

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(2) With Coadministration of CKD-828, D097 and D337 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883658
• Other study ID #: A86_09BE2108
• Status: Completed
• Phase: Phase 1
• Start date: June 4, 2021
• Est. completion date: August 19, 2021

Study information

• Verified date: January 2024
• 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(2)

Description:

An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-348(2) with coadministration of CKD-828, D097 and D337 in healthy adult volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 19, 2021
• Est. primary completion date: July 20, 2021
• 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:

• Systolic Blood Pressure: 90 to 139 mmHg

• 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 8 weeks or 4 weeks 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

• Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)

• 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(2)
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(2)	AUCt: Area under the concentration-time curve from time zero to time	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(2)	Cmax: Maximum plasma concentration of the drug	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(2)	AUCinf: Area under the concentration-time curve from zero up to 8	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(2)	Tmax: Time to maximum plasma concentration	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(2)	AUCt/AUCinf	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(2)	T1/2: Terminal elimination half-life	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