NCT03671941

Brief Summary

A randomized, open-label, single dose, crossover study to evaluate pharmacokinetic profiles and safety/tolerability of CKD-357 in healthy volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2018

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

10 days

First QC Date

September 13, 2018

Last Update Submit

September 18, 2018

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

  • AUCt of Ticagrelor

    Area under the plasma concentration of Ticagrelor versus time curve from time zero to time of last quantifiable concentration

    Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  • Cmax of Ticagrelor

    Maximum plasma concentration of Ticagrelor

    Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

Secondary Outcomes (10)

  • AUCinf of Ticagrelor

    Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  • Tmax of Ticagrelor

    Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  • t1/2 of Ticagrelor

    Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  • CL/F of Ticagrelor

    Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  • Vd/F of Ticagrelor

    Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours

  • +5 more secondary outcomes

Study Arms (2)

Group A

ACTIVE COMPARATOR

D578 Tab. 1T

Drug: D578

Group B

EXPERIMENTAL

CKD-357 Tab. 1T

Drug: CKD-357

Interventions

D578DRUG

D578 Tab.1T single oral administration under fasting condition

Also known as: Ticagrelor
Group A
CKD-357DRUG

CKD-357 Tab.1T single oral administration under fasting condition

Also known as: Novel salts of Ticagrelor
Group B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A healthy adult whose age is over 19 years old when visiting for initial screening test
  • Body mass index(BMI) between 17.5\~30.5 kg/m\^2 and the body weight must be over 55kg (Body mass index (BMI) = weight (kg) / height (m)\^2)
  • A person with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
  • Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, viral/bacterial test, the electrocardiogram (ECG), and etc.
  • The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
  • The participants must have an ability and willingness to participate throughout the entire trials

You may not qualify if:

  • A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, respiratory, gastrointestinal, urinary system, cardiovascular, liver, mental, nervous, or allergic(except subclinical seasonal allergies that is not treated at injection) disease.
  • Who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy)
  • Who had following results after examination
  • a. ALT or AST \> twice higher than normal value
  • Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (!2%) (125 mL) = 12g)
  • Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial.
  • Whose blood pressure \< 100 or ≥140(systolic blood pressure) or \< 70 or ≥ 90(diastolic blood pressure)
  • Who had a medical history of alcohol and drug abuses.
  • Who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing durg.
  • Who smokes more than 20 cigarettes per day within 6 months of the screening
  • Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very first clinical testing drug.
  • Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs
  • Who has a potent to increase a danger by participating in the clinical trials or sho can interrupt interpreting test results by having serious or chronic medical and mental status or having issues in results of the screening examination.
  • Who has a history of an extreme sensitivity of composition of the drug
  • Who has hemorrhagic tendency(recently trauma, recently surgery, coagulation disorder, recently gastrointestinal bleeding)and are scheduled for surgery within one month
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Kyung-Ho Jang, Professor

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

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

September 13, 2018

First Posted

September 14, 2018

Study Start

May 25, 2018

Primary Completion

June 4, 2018

Study Completion

June 18, 2018

Last Updated

September 19, 2018

Record last verified: 2018-09

Locations

KR(1)