Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet

January 11, 2016 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers

The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.

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

A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers

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.
40

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

  • Korea, Republic of
    • Jung-gu
      • Daejeon, Jung-gu, Korea, Republic of, 301-721
        • Chungnam National University Hospital

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 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy male volunteer in the age of 19-45
  2. Body weight ≥ 55kg and in the range of calculated Ideal Body Weight ± 20%
  3. Subject without a hereditary problems, chronic disease and morbid symptom
  4. Subject who sign on an informed consent form willingly

Exclusion Criteria:

  1. Clinically significant disease with hepatobiliary, nephrological, gastrointestinal, respiratory, hepato-oncological, endocrine, urogenital, neurologic, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
  2. Gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) or gastrointestinal surgery(except for appendectomy or herniotomy)
  3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives
  4. Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
  5. Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
  6. Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range
  7. Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
  8. The history of drug abuse or drug abuse showed a positive for urine drug test
  9. Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 1 month
  10. Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
  11. Taking drugs have received any other investigational drug within 3 months prior to the first dosing
  12. Whole blood donation within 2 months prior to the first dosing or component blood donation within 1 months prior to the first dosing or blood transfusion within 1 month
  13. Continuously taking excessive alcohol (> 21 units/week; 1 unit = 10g of pure alcohol) or cannot stop drinking from 24 hours before admission to discharge
  14. Cigarette > 10 cigarettes a day on average for recent 3 months
  15. Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
  16. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason

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
  • 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.
ACTIVE_COMPARATOR: Viread® tablet
Tenofovir Disoproxil Fumarate
Drug: Viread® tablet
Tenofovir Disoproxil Fumarate 1T PO
EXPERIMENTAL: CKD-390
Tenofovir Disoproxil Fumarate
Drug: CKD-390
Tenofovir Disoproxil Aspartate 1T PO

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
Time Frame
AUCt of Tenofovir
Time Frame: 0(Pre-dose) up to 72hr
0(Pre-dose) up to 72hr

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
Time Frame
AUCinf
Time Frame: 0(Pre-dose) up to 72hr
0(Pre-dose) up to 72hr
Blood pressure
Time Frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
tmax
Time Frame: 0(Pre-dose) up to 72hr
0(Pre-dose) up to 72hr
t1/2β
Time Frame: 0(Pre-dose) up to 72hr
0(Pre-dose) up to 72hr
Clearance/F
Time Frame: 0(Pre-dose) up to 72hr
0(Pre-dose) up to 72hr
Electrocardiography
Time Frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Physical Examination
Time Frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Pulse rate
Time Frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Temperature
Time Frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day

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

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.
October 1, 2015

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.
December 1, 2015

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.
December 1, 2015

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).
October 6, 2015

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.
October 27, 2015

First Posted (ESTIMATE)

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.
October 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

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.
January 12, 2016

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.
January 11, 2016

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.
January 1, 2016

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.
  • 163BE15028

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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