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Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Harnal-D Tab.
Chong Kun Dang Tamsulosin HCl Tab.
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy subject older than 19 years men at the screening
  2. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
  3. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.)

  4. Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2

    * BMI = Weight(kg)/ Height(m)2

  5. Individuals who had agreed to participate in the study
  6. Individuals without mental illness history within five year prior to the screening
  7. Individuals without a medical history of gastrointestinal operations that may affect drug absorption
  8. Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration

Exclusion Criteria:

  1. Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month

  2. Individuals who had excessive drinking within the 1 month

    *Men: 21 glasses/week exceeded(1 glass: distilled spirits 45 mL, wine 150 mL, beer 360 mL)

  3. Individuals who had taken any medication within 10 days prior to the first day of dosing
  4. Individuals who were deemed to be inappropriate to participate in the study by the investigator
  5. Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
  6. Individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s)
  7. Individuals with hypersensitivity (include Vascular edema) to ingredients used in the investigational product(s)
  8. Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
  9. Individuals with orthostatic hypotension
  10. Individuals with severe hepatopathy
  11. Individuals who had taken alpha-1 blocker
  12. Individuals who had history of micturition syncope
  13. Individuals with nephropathy
  14. Elderly person
  15. Individuals who had taken PDE5(phosphodiesterase-5) inhibitor
  16. Individuals who had taken CYP3A4 inhibitor
  17. Individuals who had taken antihypertensive drug(s)

Sites / Locations

  • Bestian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Reference/Test

Test/Reference

Arm Description

Period 1: Harnal-D Tab. 1T Period 2: Chong Kun Dang Tamsulosin HCl Tab. 1T

Period 1: Chong Kun Dang Tamsulosin HCl Tab. 1T Period 2: Harnal-D Tab. 1T

Outcomes

Primary Outcome Measures

AUCt of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
Area under the Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood-time curve from zero to final
Cmax of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
The maximum Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood sampling time t

Secondary Outcome Measures

Full Information

First Posted
March 21, 2019
Last Updated
January 28, 2020
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03887858
Brief Title
Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers
Official Title
An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers
Detailed Description
To healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week. Reference drug: Harnal-D Tab. / Test drug: Chong Kun Dang Tamsulosin HCl Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reference/Test
Arm Type
Experimental
Arm Description
Period 1: Harnal-D Tab. 1T Period 2: Chong Kun Dang Tamsulosin HCl Tab. 1T
Arm Title
Test/Reference
Arm Type
Experimental
Arm Description
Period 1: Chong Kun Dang Tamsulosin HCl Tab. 1T Period 2: Harnal-D Tab. 1T
Intervention Type
Drug
Intervention Name(s)
Harnal-D Tab.
Intervention Description
Harnal-D Tab. 1T single oral administration under fasting
Intervention Type
Drug
Intervention Name(s)
Chong Kun Dang Tamsulosin HCl Tab.
Intervention Description
Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration under fasting condition
Primary Outcome Measure Information:
Title
AUCt of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
Description
Area under the Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood-time curve from zero to final
Time Frame
Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
Title
Cmax of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
Description
The maximum Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood sampling time t
Time Frame
Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subject older than 19 years men at the screening Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography) Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.) Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2 * BMI = Weight(kg)/ Height(m)2 Individuals who had agreed to participate in the study Individuals without mental illness history within five year prior to the screening Individuals without a medical history of gastrointestinal operations that may affect drug absorption Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration Exclusion Criteria: Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month Individuals who had excessive drinking within the 1 month *Men: 21 glasses/week exceeded(1 glass: distilled spirits 45 mL, wine 150 mL, beer 360 mL) Individuals who had taken any medication within 10 days prior to the first day of dosing Individuals who were deemed to be inappropriate to participate in the study by the investigator Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing Individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s) Individuals with hypersensitivity (include Vascular edema) to ingredients used in the investigational product(s) Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc. Individuals with orthostatic hypotension Individuals with severe hepatopathy Individuals who had taken alpha-1 blocker Individuals who had history of micturition syncope Individuals with nephropathy Elderly person Individuals who had taken PDE5(phosphodiesterase-5) inhibitor Individuals who had taken CYP3A4 inhibitor Individuals who had taken antihypertensive drug(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Jung Cha
Organizational Affiliation
Bestian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bestian Hospital
City
Osong
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers

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