Pharmacokinetics and Safety of HCP1105 and Co-administration of HGP0918, HGP0816 in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the pharmacokinetic properties and safety after administration of HCP1105 and co-administration of HGP0918, HGP0816 in healthy male volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

Inclusion Criteria:

• Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

• Healthy male volunteers, aged 19 to 55 years.

• The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2

Exclusion Criteria:

• •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 digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system

• Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range

• Somenone has a declined kidney function and his eGFR < 60mL/min/1.73m2