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

October 19, 2016 updated by: Hanmi Pharmaceutical Company Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: Test→Reference
HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets
Drug: HGP1206
One Bosentan 125 mg tablet
Other Names:
  • Bosentan 125 mg
Drug: Traclear
Two Bosentan 62.5 mg tablets
Other Names:
  • Traclear 62.5 mg
Experimental: Reference→Test
Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet
Drug: HGP1206
One Bosentan 125 mg tablet
Other Names:
  • Bosentan 125 mg
Drug: Traclear
Two Bosentan 62.5 mg tablets
Other Names:
  • Traclear 62.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUClast
Time Frame: 0-24h
0-24h
Cmax
Time Frame: 0-24h
0-24h

Secondary Outcome Measures

Outcome Measure
Time Frame
Tmax
Time Frame: 0~24h
0~24h
AUCinf
Time Frame: 0~24h
0~24h
t1/2
Time Frame: 0~24h
0~24h

Collaborators and Investigators

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

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Wooseong Huh, MD, PhD, Samsung medical center

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

April 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 29, 2013

First Posted (Estimate)

May 30, 2013

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-BOTAN-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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