NCT01864863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

May 20, 2013

Last Update Submit

October 19, 2016

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

  • AUClast

    0-24h

  • Cmax

    0-24h

Secondary Outcomes (3)

  • Tmax

    0~24h

  • AUCinf

    0~24h

  • t1/2

    0~24h

Study Arms (2)

Test→Reference

EXPERIMENTAL

HGP1206 125 mg 1 tablet → Traclear 62.5 mg 2 tablets

Drug: HGP1206Drug: Traclear

Reference→Test

EXPERIMENTAL

Traclear 62.5 mg 2 tablets → HGP1206 125 mg 1 tablet

Drug: HGP1206Drug: Traclear

Interventions

HGP1206DRUG

One Bosentan 125 mg tablet

Also known as: Bosentan 125 mg
Reference→TestTest→Reference
TraclearDRUG

Two Bosentan 62.5 mg tablets

Also known as: Traclear 62.5 mg
Reference→TestTest→Reference

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, South Korea

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wooseong Huh, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 30, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)