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

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ClinicalTrials.gov Identifier: NCT01864863
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: HGP1206 Drug: Traclear Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013


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 Name: Bosentan 125 mg

Drug: Traclear
Two Bosentan 62.5 mg tablets
Other Name: 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 Name: Bosentan 125 mg

Drug: Traclear
Two Bosentan 62.5 mg tablets
Other Name: Traclear 62.5 mg




Primary Outcome Measures :
  1. AUClast [ Time Frame: 0-24h ]
  2. Cmax [ Time Frame: 0-24h ]

Secondary Outcome Measures :
  1. Tmax [ Time Frame: 0~24h ]
  2. AUCinf [ Time Frame: 0~24h ]
  3. t1/2 [ Time Frame: 0~24h ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864863


Locations
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Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Wooseong Huh, MD, PhD Samsung Medical Center

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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01864863     History of Changes
Other Study ID Numbers: HM-BOTAN-101
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action