CKD-355 Drug-drug Interaction Study (CKD-355 DDI P1)

June 15, 2018 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Effect of D797 on Pharmacokinetics of D324 in Healthy Volunteers

The purpose of this study is to evaluate a pharmacokinetic drug interaction between D797 of D324 in healthy volunteers

Study Overview

Detailed Description

To healthy subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 21 days.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • 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

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. A healthy adult whose age is over 19 years old when visiting for initial screening test
  2. 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)
  3. A person with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
  4. 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, the electrocardiogram (ECG), and etc.
  5. 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.
  6. The participants must have an ability and willingness to participate throughout the entire trials

Exclusion Criteria:

  1. A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nercous, or allergic(except subclinical seasonal allergies that is not treated at injecion) desease.
  2. Who had a gistory 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)
  3. Who had following results after examination

    a. ALT or AST > twice higher than normal value

  4. 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)
  5. Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial.
  6. Whose blood pressure < 100 or ≥140(systolic blood pressure) or < 70 or ≥ 90(diastolic blood pressure)
  7. Who had a medical history of alcohol and drug abuses.
  8. Who had taken a drug that has a control of metabolic rate (activatioh or inhibithion) in 30 days before the first taking of clinical testing durg.
  9. Who smokes more than 10 eigarettes per day.
  10. Who took prescribed drugs or over-the-conuter durgs in 10 days before taking of very first clinical testing drug.
  11. 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.
  12. Who has a potent to increase a danger by participating in the clinical trials or sho can interrupt interpretin test results by having serious or chronic medical and mental status or having issues in results of the screening examination.
  13. Who has a histroy of an extreme sensitivity of drugs that contain donepezil hydrochloride, piperidine derivatives, memantine hydrochloride drugs.

    Who has a serious heart failure or a congestive heart failure that must be drug-treated

  14. Who has a Pregnant or potentially pregnant.
  15. Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders.
  16. A patient with severe hepatopathy
  17. A patient with moderate nephropathy.
  18. A person who is not determined unsuitable to participate in this test by the researchers.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1(Treatment A/Treatment B)

Period 1: Treatment A(Memantine Tab. 10mg)*2T, QD, PO.

Period 2: Treatment B(Memantine Tab. 10mg)*2T + Donepezil Tab. 10mg)*1T, QD, PO.

Each treatment period was separated by a washout period of at least 21 dyas.

Memantine Tab. 10mg* 2T/day, QD, PO
Other Names:
  • Ebixa Tab. 10mg
Memantine Tab. 10mg* 2T/day + Donepezil Tab. 10mg * 1T/day, QD, PO
Other Names:
  • Ebixa Tab. 10mg + Aricept Tab. 10mg
Experimental: Group 1(Treatment B/Treatment A)

Period 1: Treatment B(Memantine Tab. 10mg)*2T + Donepezil Tab. 10mg)*1T, QD, PO.

Period 2: Treatment A(Memantine Tab. 10mg)*1T, QD, PO.

Each treatment period was separated by a washout period of at least 21 dyas.

Memantine Tab. 10mg* 2T/day, QD, PO
Other Names:
  • Ebixa Tab. 10mg
Memantine Tab. 10mg* 2T/day + Donepezil Tab. 10mg * 1T/day, QD, PO
Other Names:
  • Ebixa Tab. 10mg + Aricept Tab. 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt of Memantine
Time Frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Area under the plasma concentration of Memantine versus time curve from time zero to time of last quantifiable concentration
1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Cmax of Memantine
Time Frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Maximum plasma concentration of Memantine
1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf of Memantine
Time Frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Area under the plasma concentration of Memantine versus time curve from time zero to time infinity
1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Tmax of Memantine
Time Frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Time to maximum concentration of of Memantine
1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
t1/2 of Memantine
Time Frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Apparent terminal half-life of Memantine
1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
CL/F of Memantine
Time Frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Total body clearance of Memantine
1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Vd/F of Memantine
Time Frame: 1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h
Apparent volume of distribution of Memantine
1Day 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 12h, 24h, 48h, 72h, 120h, 168h, 216h

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Kyung-Ho Jang, Professor, Chonbuk National University Hospital

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)

April 16, 2018

Primary Completion (Actual)

May 21, 2018

Study Completion (Actual)

June 4, 2018

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

June 15, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 15, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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