A Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of CKD-333 or Co-administration of CKD-333 and D085 in Healthy Volunteers

NCT04627207 | Unknown Phase 1

• 1 other identifier: A70_10BE2006
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

A clinical trial to evaluate the safety and pharmacokinetic characteristics of CKD-333 or Co-administration of CKD-333 and D085 in healthy volunteers

Conditions

Cardiovascular Diseases

Keywords

CKD-333

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-330, D085, CKD-333

  Area under the CKD-330/D085/CKD-333 concentration in blood-time curve from zero to final

  Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

• Cmax of CKD-330, D085, CKD-333

  The maximum CKD-330/D085/CKD-333 concentration in blood sampling time t

  Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Study Arms (3)

Reference-Reference-Test

EXPERIMENTAL

Sequence 1

Drug: CKD-330 1 Tab. and D085 1 Tab.; Drug: CKD-333 1 Tab

Reference-Test-Reference

EXPERIMENTAL

Sequence 2

Drug: CKD-330 1 Tab. and D085 1 Tab.; Drug: CKD-333 1 Tab

Test-Reference-Reference

EXPERIMENTAL

Sequence 3

Drug: CKD-330 1 Tab. and D085 1 Tab.; Drug: CKD-333 1 Tab

Interventions

CKD-330 1 Tab. and D085 1 Tab. DRUG

Other names: Reference

Reference-Reference-Test; Reference-Test-Reference; Test-Reference-Reference

CKD-333 1 Tab DRUG

Other names: Test

Reference-Reference-Test; Reference-Test-Reference; Test-Reference-Reference

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers aged 19≤ \~ \<55-year-old.
• Those who have body weight ≥ 55kg (men) or ≥ 45kg (women), with calculated body mass index(BMI) of 17.5 ≤ \~ \< 30.5 kg/m2
• Those who have no congenital/chronic diseases, abnormal symptoms.
• Those who were deemed to eligible for participation of clinical trial by laboratory tests, vital signs and 12-lead ECG etc.
• Those who voluntarily decide to participate and agree to comply with the cautions and fully understanding the detailed description of this clinical trial.
• Those who consent to proper contraception during the study period and do not donate sperm until 14 days after the last administration of investigational product. And those who consent not to become pregnant or breastfeeding.
• Those who have ability and willingness to participate in clinical trial

You may not qualify if:

• Those who have medical history or medical symptom of liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or mental disease.
• Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug.
• Those who have the test results written below,
• AST or ALT are 2 times higher than upper normal range
• Creatinine is upper normal range or eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) \< 60 mL/min/1.73m2
• QTc is higher than 450msec measured by 12-lead ECG
• CPK is 3 times higher than upper normal range
• Serum Potassium is higher than 5.5 mEq/L
• Hematocrit is under normal range
• Those who exceed alcohol consumption criteria (21 units/week within 3 months) prior to first administration of investigational product. Or Those who can't quit drinking alcohol from 48 hours to end of bleeding time point.
• Those who exceed smoke criteria (20 cigarettes/day within 6 months) prior to first administration of investigational product. Or Those who can't quit smoking during hospitalization.
• Those who have participated in other clinical trial and received Investigational product within 6 month prior to the first administration of drug.
• Those who have the test results written below,
• Systolic blood pressure ≥140 mmHg or \<90 mmHg
• Diastolic blood pressure ≥90 mmHg or \<60 mmHg

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Related Publications (1)

• Kim JH, Song JH, Kim M, Hong JH, Sunwoo J, Jung JG. Pharmacokinetic Comparison of a Fixed-Dose Combination of Candesartan Cilexetil/Amlodipine/Atorvastatin Versus Co-administration of Individual Formulations in Healthy Participants. Adv Ther. 2024 Jul;41(7):2808-2825. doi: 10.1007/s12325-024-02869-y. Epub 2024 May 21.

  PMID: 38771476 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Hong Jang Hee, M.D.

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Jang Hee, M.D.

CONTACT

+82-42-280-6940; boniii@cnu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 13, 2020
• Study Start: November 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share