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OpenTrials
Completed

NCT Number: NCT01864863

To Compare the Pharmacokinetics of Traclear 62.5 mg 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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung medical center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HGP1206

Drug

One Bosentan 125 mg tablet

Other names: Bosentan 125 mg

Traclear

Drug

Two Bosentan 62.5 mg tablets

Other names: Traclear 62.5 mg

Primary outcomes

  1. AUClast

    Time frame: 0-24h

  2. Cmax

    Time frame: 0-24h

Secondary outcomes

  1. Tmax

    Time frame: 0~24h

  2. AUCinf

    Time frame: 0~24h

  3. t1/2

    Time frame: 0~24h

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 30, 2013
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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