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: AUClastCmax
Secondary outcome: TmaxAUCinf 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
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