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

Information source: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bioequivalence Study

Intervention: HGP1206 (Drug); Traclear (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hanmi Pharmaceutical Company Limited

Summary

The purpose of this study is to compare the pharmacokinetics of Traclear 62. 5 mg 2 tablets and HGP1206 125 mg 1 tablet in healthy male volunteers.

Clinical Details

Official title: An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

AUClast

Cmax

Secondary outcome:

Tmax

AUCinf

t1/2

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Healthy male

- Age between 20 and 55

- Signed informed consent

Exclusion Criteria:

- Has a history of Primary pulmonary hypertension to IP ingredients

- Hypotension or hypertension

Locations and Contacts

Samsung medical center, Seoul, Korea, Republic of
Additional Information

Starting date: April 2013
Last updated: May 29, 2013

Page last updated: August 23, 2015

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