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To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HGP1206
Traclear
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

20 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male
  • Age between 20 and 55
  • Signed informed consent

Exclusion Criteria:

  • Has a history of Primary pulmonary hypertension to investigational product ingredients
  • Hypotension or hypertension

Sites / Locations

  • Samsung medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Test→Reference

Reference→Test

Arm Description

HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets

Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet

Outcomes

Primary Outcome Measures

AUClast
Cmax

Secondary Outcome Measures

Tmax
AUCinf
t1/2

Full Information

First Posted
May 20, 2013
Last Updated
October 19, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01864863
Brief Title
To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers
Official Title
An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics of Traclear 62.5 mg 2 Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the pharmacokinetics of two Traclear 62.5 mg tablets and one HGP1206 125 mg tablet in healthy male volunteers.
Detailed Description
An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and safety of Traclear 62.5 mg Tablets and HGP1206 125mg Tablet in Healthy Male Volunteers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Test→Reference
Arm Type
Experimental
Arm Description
HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets
Arm Title
Reference→Test
Arm Type
Experimental
Arm Description
Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet
Intervention Type
Drug
Intervention Name(s)
HGP1206
Other Intervention Name(s)
Bosentan 125 mg
Intervention Description
One Bosentan 125 mg tablet
Intervention Type
Drug
Intervention Name(s)
Traclear
Other Intervention Name(s)
Traclear 62.5 mg
Intervention Description
Two Bosentan 62.5 mg tablets
Primary Outcome Measure Information:
Title
AUClast
Time Frame
0-24h
Title
Cmax
Time Frame
0-24h
Secondary Outcome Measure Information:
Title
Tmax
Time Frame
0~24h
Title
AUCinf
Time Frame
0~24h
Title
t1/2
Time Frame
0~24h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male Age between 20 and 55 Signed informed consent Exclusion Criteria: Has a history of Primary pulmonary hypertension to investigational product ingredients Hypotension or hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wooseong Huh, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung medical center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers

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