A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355

October 21, 2019 updated by: Chong Kun Dang Pharmaceutical

An Open-label, Randomized, Multiple-dosing Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355 With D797 and D324 in Healthy Subjects

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy adult older than 19 years and less than 55 years at the time of screening
  2. BMI 18.5~29.9 kg/m2 and body weight more than 50kg
  3. Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men
  4. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

  1. Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
  2. Subjects who have acute disease within 28 days prior to the first administration
  3. Subjects who have history that may affect the ADME
  4. Subjects who have clinically significant chronic disease
  5. Women who are nursing, pregnant or positive on pregnancy test
  6. Subjects who have clinically significant allergic diseases
  7. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  8. Subjects who are known to be hypersensitive to the drug or its components
  9. Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
  10. Subjects with creatinine clearance <60 ml / min
  11. Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
  12. Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration
  13. Subjects who can not eat standard meals provided by the institution.
  14. Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
  15. Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
  16. Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice>1 L / day)
  17. Subjects who participate in the other clinical trial within 90 days prior to the first administration
  18. Subjects who have a history of regular alcohol(alcohol>210g/week) or caffeine(caffeine>5 cups/day)
  19. Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial
  20. Subjects who is determined unsuitable to participate in this clinical trial by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: CKD-355A
Drug: CKD-355A (D797/Memantine HCl 20mg)
once a day
EXPERIMENTAL: CKD-355B
Drug: CKD-355B (D797/Memantine HCl 20mg)
once a day
ACTIVE_COMPARATOR: D797, D324
Drug: D797
once a day
Drug: D324 (Memantine HCl 10mg)
twice a day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax of D324
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Max Concentration of D324
0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
AUCt of D324
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Area under the curve of D324
0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Cmax of D797
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Max Concentration of D797
0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
AUCt of D797
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Area under the curve of D797
0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmin of D324
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Min Concentration of D324
0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Cmin of D797
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Min Concentration of D797
0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Tmax of D324
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Time of Max concentration of D324
0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Tmax of D797
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Time of Max concentration of D797
0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
t½ of D324
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Half-life time of D324
0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
t½ of D797
Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Half-life time of D797
0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 179BE18029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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