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A Randomized, Open-label, Single dose, 3-Treatment, 3-Period Williams-Design to Assess the Pharmacokinetic Characteristics and Food Effect of Levodropropizine Controlled-Release Tablets Compared with Levodropropizine Immediate-Release Tablets in Healthy Male Subjects

Status Approved

  • First Submitted Date

    2017/04/09

  • Registered Date

    2017/07/21

  • Last Updated Date

    2017/07/20

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0002383
    Unique Protocol ID CNUH 2011-12-019
    Public/Brief Title The Pharmacokinetic Characteristics and Food Effect of Levodropropizine Controlled-Release Tablets Compared with Levodropropizine Immediate-Release Tablets
    Scientific Title A Randomized, Open-label, Single dose, 3-Treatment, 3-Period Williams-Design to Assess the Pharmacokinetic Characteristics and Food Effect of Levodropropizine Controlled-Release Tablets Compared with Levodropropizine Immediate-Release Tablets in Healthy Male Subjects
    Acronym KUP-LDP4-101
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry No
    Healthcare Benefit Approval Status

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CNUH 2011-12-019
    Approval Date 2011-12-22
    Institutional Review Board Name Chungnam National University Hospital Instituitional Review Board
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name JangHee Hong
    Title Professor
    Telephone +82-42-280-6940
    Affiliation Chungnam National University Hospital
    Address 282, Munhwa-ro, Jung-gu, Daejeon
    Contact Person for Public Queries
    Name JangHee Hong
    Title Professor
    Telephone +82-42-280-6940
    Affiliation Chungnam National University Hospital
    Address 282, Munhwa-ro, Jung-gu, Daejeon
    Contact Person for Updating Information
    Name JangHee Hong
    Title Professor
    Telephone +82-42-280-6940
    Affiliation Chungnam National University Hospital
    Address 282, Munhwa-ro, Jung-gu, Daejeon

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2012-06-29 Actual
    Target Number of Participant 48
    Primary Completion Date 2012-09-25 , Actual
    Study Completion Date 2012-12-20 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Chungnam National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2012-06-29 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea United Pharm
    Organization Type Pharmaceutical Company
    Project ID

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea United Pharm
    Organization Type Pharmaceutical Company

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    1. Purpose
 : The aim of this study was to compare the PK profile between levodropropizine CR formulation and levodropropizine IR formulation in fasted state. In addition, we evaluated the effects of food on the PK of levodropropizine CR formulation in healthy male subjects.

2. Target: Healthy male volunteers 

3. Condition: Cough by acute or chronic bronchitis

4. Endpoint 
(1) Pharmacokinetic evaluation: AUCt, Cmax, AUCinf, tmax, t1/2β, CL/F of levodropropizine
(2) Safety evaluation: Adverse event, Vital sign, Physical exam, 12-lead ECG, Laboratory test(CBC, Chemistry, Urine)  



Background : Currently available dosage form, levodropropizine immediate release (IR) tablet 60 mg, is prescribed for three times a day for a total daily dose of 180 mg. To improve the dosing convenience and patients’ compliance, levodropropizine controlled release (CR) tablet is in development by Korea United Pharm Inc (Seoul, Republic of Korea). 
Study design : This study was a randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence Williams-design crossover study. Subjects were randomly assigned to one of six treatment sequences to receive following three treatments; levodropropizine IR 60 mg three times in every 6 h under fasting state, levodropropizine CR 90 mg two times in every 12 h under fasting sate, and levodropropizine CR 90 mg two times in every 12 h under fed state

  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose 
    Treatment
    Phase Phase1
    Intervention Model Cross-over  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug  
    Intervention Description 
    1. Arm A 
(1) Period 1 :	R
(2) Period 2 :	T
(3) Period 3 :	TF
2. Arm B
(1) Period 1 : TF
(2) Period 2 : R
(3) Period 3 : T
3. Arm C
(1) Period 1 : T
(2) Period 2 : TF
(3) Period 3 : R
4. Arm D
(1) Period 1 : TF
(2) Period 2 : T
(3) Period 3 : R
5. Arm E
(1) Period 1 : T
(2) Period 2 : R	
(3) Period 3 : TF
6. Arm F
(1) Period 1 : R
(2) Period  2 : TF
(3) Period 3 : T
• R : Reference/fasting Treatment (Levodropropizine 60 mg, PO, Tid/day)
• T : Test/fasting Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
• TF : Test/fed Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
    Number of Arms 6
    Arm 1

    Arm Label

    Arm A

    Target Number of Participant

    8

    Arm Type

    Others

    Arm Description

    Arm A 
(1) Period 1 :	R
(2) Period 2 :	T
(3) Period 3 :	TF
- washout : 7 days
• R : Reference/fasting Treatment (Levodropropizine 60 mg, PO, Tid/day)
• T : Test/fasting Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
• TF : Test/fed Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
    Arm 2

    Arm Label

    Arm B

    Target Number of Participant

    8

    Arm Type

    Others

    Arm Description

    Arm B
(1) Period 1 : TF
(2) Period 2 : R
(3) Period 3 : T
- washout : 7 days
• R : Reference/fasting Treatment (Levodropropizine 60 mg, PO, Tid/day)
• T : Test/fasting Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
• TF : Test/fed Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
    Arm 3

    Arm Label

    Arm C

    Target Number of Participant

    8

    Arm Type

    Others

    Arm Description

    Arm C
(1) Period 1 : T
(2) Period 2 : TF
(3) Period 3 : R
- washout : 7 days
• R : Reference/fasting Treatment (Levodropropizine 60 mg, PO, Tid/day)
• T : Test/fasting Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
• TF : Test/fed Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
    Arm 4

    Arm Label

    Arm D

    Target Number of Participant

    8

    Arm Type

    Others

    Arm Description

    Arm D
(1) Period 1 : TF
(2) Period 2 : T
(3) Period 3 : R
- washout : 7 days
• R : Reference/fasting Treatment (Levodropropizine 60 mg, PO, Tid/day)
• T : Test/fasting Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
• TF : Test/fed Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
    Arm 5

    Arm Label

    Arm E

    Target Number of Participant

    8

    Arm Type

    Others

    Arm Description

    Arm E
(1) Period 1 : T
(2) Period 2 : R	
(3) Period 3 : TF
- washout : 7 days
• R : Reference/fasting Treatment (Levodropropizine 60 mg, PO, Tid/day)
• T : Test/fasting Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
• TF : Test/fed Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
    Arm 6

    Arm Label

    Arm D

    Target Number of Participant

    8

    Arm Type

    Others

    Arm Description

    Arm F
(1) Period 1 : R
(2) Period  2 : TF
(3) Period 3 : T
- washout : 7 days
• R : Reference/fasting Treatment (Levodropropizine 60 mg, PO, Tid/day)
• T : Test/fasting Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)
• TF : Test/fed Treatment (UI04LDP090CT (Levodropropizine 90 mg), PO, Bid/day)

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC 
       (R05)Cough 
    Rare Disease No
    Inclusion Criteria

    Gender

    Male

    Age

    20Year~55Year

    Description

    1. Healthy male volunteer in the age of 20-55 
2. Body weight ≥ 55 kg and in the range of calculated IBW(Ideal Body Weight) ±20% 
3. Subject without a hereditary problems, chronic disease and morbid symptom 
4. Suitable clinical laboratory test values 
5. Subject who sign on an informed consent form willingly
    Exclusion Criteria 
    1. History of significant hypersensitivity reaction of levodropropizine or anti-tussive drugs
2. Sitting systolic blood pressure ≥ 145 mmHg or< 95 mmHg, sitting diastolic blood pressure ≥ 100 mmHg or < 50 mmHg, pulse ≥ 100 beats per minute
3. Clinically significant disease with hepatobiliary, nephrological, neurologic, respiratory, haemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
4. Galactose intolerance
5. Significant cardiac arrhythmia, QT prolongation (>450 m/sec)
6. Gastrointestinal disease or gastrointestinal surgery
7. Medical history gastric ulcer or gastric hemorrhage within 2 months
8. Continuously taking Alcohol > 21 units/week, Cigarette > 10 cigarettes/day
9. Subject treated Investigational product(include Bioequivalence test) within 3 months
10. Whole blood donation within 2 months, component blood donation or blood transfusion within 1 month
11. Subject treated metabolizing enzyme inducers or inhibitors within 1 month
12. Subject treated ethical the counter or herbal medicine within 2 weeks, weeks, over-the-counter or vitamin within 1 week
13. Psychological disease, alcoholism
14. Another clinical condition in judgement of investigator
15. Subject treated grapefruit juice within 1 week
16. Drug abuse
    Healthy Volunteers Yes

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Pharmacokinetics
    Primary Outcome(s) 1
    Outcome 
    AUClast of levodropropizine
    Timepoint 
    Reference drug (total 23) : predose (0h) (1st administration), 0.25, 0.50, 0.75, 1, 2, 4, 6(2nd administration), 6.25, 6.50, 6.75, 7, 8, 10, 12(3rd administration), 12.25, 12.50, 12.75, 13, 14, 16, 18, 24 h.  Test drug(total 20) : predose (0h) (1st administration), 0.25, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 12 (2nd administration), 12.25, 12.50, 12.75, 13, 14, 15, 16, 18, 24 h
    Primary Outcome(s) 2
    Outcome 
    Cmax of levodropropizine
    Timepoint 
    Reference drug (total 23) : predose (0h) (1st administration), 0.25, 0.50, 0.75, 1, 2, 4, 6(2nd administration), 6.25, 6.50, 6.75, 7, 8, 10, 12(3rd administration), 12.25, 12.50, 12.75, 13, 14, 16, 18, 24 h.  Test drug(total 20) : predose (0h) (1st administration), 0.25, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 12 (2nd administration), 12.25, 12.50, 12.75, 13, 14, 15, 16, 18, 24 h
    Secondary Outcome(s) 1
    Outcome 
    AUCinf, T1/2, Tmax of Levodropropizine
    Timepoint 
    Reference drug (total 23) : predose (0h) (1st administration), 0.25, 0.50, 0.75, 1, 2, 4, 6(2nd administration), 6.25, 6.50, 6.75, 7, 8, 10, 12(3rd administration), 12.25, 12.50, 12.75, 13, 14, 16, 18, 24 h.  Test drug(total 20) : predose (0h) (1st administration), 0.25, 0.50, 0.75, 1, 2, 3, 4, 6, 8, 12 (2nd administration), 12.25, 12.50, 12.75, 13, 14, 15, 16, 18, 24 h
    Secondary Outcome(s) 2
    Outcome 
    Safety evaluation: Adverse event, Vital sign, Physical exam, 12-lead ECG, Laboratory test(CBC, Chemistry, Urine)
    Timepoint 
    Screening period, Pre-dose, Post-dose, Post-visiting

  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered

  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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