Study to Evaluate the Safety and Pharmacokinetics of CKD-331

Hypertension and Dyslipidemia Clinical Trial

Official title:

An Open-label, Randomized, Single-dose, 2-sequence, 4-period, Cross-over, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-331 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05335044
• Other study ID #: A124_01BE2203
• Status: Completed
• Phase: Phase 1
• Start date: May 31, 2022
• Est. completion date: July 12, 2022

Study information

• Verified date: June 2023
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers

Description:

An open-label, randomized, single-dose, 2-sequence, 4-period, cross-over, phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 12, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Healthy adult volunteers aged = 19 years

2. Weight =55kg with calculated body mass index (BMI) of 18 to 30 kg/m2

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

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

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

6. 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 have no medical history of digestive disease, cardiovascular disease, endocrine disease, respiratory system, blood·tumor disease, infection disease, nephrology disease, genitourinary disease, neuron disease, skeletal disease, immunological disease, otolaryngological disease, dermatological disease, ophiological disease

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

3. 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.

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

5. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.

6. 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

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-331
QD, PO
• EX5619
QD, PO

Locations

Country	Name	City	State
Korea, Republic of	H plus Yangji hospital	Seoul

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 of CKD-331	Cmax: Maximum plasma concentration of the drug	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours
Primary	AUCt of CKD-331	AUCt: Area under the concentration-time curve from time zero to time	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours