Clinical Trial to Compare the Pharmacokinetics and Pharmacodynamics After Oral Administration of Glucophage and HL-018

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is designed to to compare the pharmacokinetic and pharmacodynamic characteristics and safety after oral administration of Glucophage with those after oral administration of HL-018 in healthy male volunteers

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

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: HanAll BioPharma Co., Ltd.
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Adult males aged 19 to 50 years at screening.

• No significant congenital/chronic disease. No symptoms in physical examination.

• Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.

• Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

• History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.

• History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

• History of known hypersensitivity to drugs including metformin.