Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers

NCT04478097 | Unknown Phase 1

• 1 other identifier: A70_09BE2005
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open, single-dose, 3 period partial replicated crossover-design study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-330, D086, CKD-333

  Area under the CKD-330/D086/CKD-333 concentration in blood-time curve from zero to final

  [Time Frame: 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, D086, CKD-333

  The maximum CKD-330/D086/CKD-333 concentration in blood sampling time t

  [Time Frame: 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

Drug: CKD-330 Tab. and D086 Tab.; Drug: CKD-333 Tab.

Reference-Test-Reference

EXPERIMENTAL

Drug: CKD-330 Tab. and D086 Tab.; Drug: CKD-333 Tab.

Test-Reference-Reference

EXPERIMENTAL

Drug: CKD-330 Tab. and D086 Tab.; Drug: CKD-333 Tab.

Interventions

CKD-330 Tab. and D086 Tab. DRUG

1T

Also known as: Reference

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

CKD-333 Tab. DRUG

1T

Also known as: 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 adults over the age of 19 years and under the age of 55 years at the time of screening
• Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) \< 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
• \* BMI = Weight(kg)/ Height(m)2
• Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
• Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screening
• Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
• Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
• Individuals with the ability and willingness to participate the entire study period

You may not qualify if:

• Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
• Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
• Individuals with the following results at screening test:
• ALT or AST \> 2x the upper limit of the normal range
• Creatinine \> upper limit of the normal range or eGFR with MDRD \<60 ml/min/1.73 m2
• ECG Result, QTc \> 450msec
• CPK \> UNL(upper normal limit) x 3.0
• K \> 5.5mEq/l
• Hct \< lower limit of the normal range
• A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first dose to end of last blooding (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
• Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening or cannot quit smoking during hospitalization period
• Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
• Following vital signs results at screening
• Sitting systolic blood pressure ≥ 140 mmHg or \< 90 mmHg
• sitting diastolic blood pressure ≥90 mmHg or \<60 mmHg

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Jang Hee Hong

Daejeon, South Korea

Location

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 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: July 17, 2020
• First Posted: July 20, 2020
• Study Start: July 14, 2020
• Primary Completion: November 5, 2020
• Study Completion: January 1, 2021
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)