An open-label, randomized, single-dose, 2way crossover study to compare the pharmacokinetics of Traclear 62.5 mg 2 tablets and HGP1206 125 mg 1 tablet in healthy male volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000802

Enrollment

Registered

2013-07-23

Start date

2013-04-23

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HGP1206 125mg 1T under fasted condition. In period 2, the subjects will

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1.Healthy male volunteers, age 20 to 55 years. 2.The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2

Exclusion criteria

Exclusion criteria: 1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. 2. Hypersensitive reactions to traclear, or other drugs (aspirin, antibiotics ect.) or, history of clinically significant hypersensitive reactions

Design outcomes

Primary

Measure	Time frame
Cmax;AUC last	—

Secondary

Measure	Time frame
AUCinf	—

Countries

Korea, Republic of

Contacts

Public ContactTae-Eun Kim

Samsung Medical Center

Outcome results