Trial | NCT01232036  Report issue

Title

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

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    metformin sitagliptin ...

  • Study Participants

    28
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
Study Started
May 31
2010
Primary Completion
Aug 31
2010
Study Completion
Oct 31
2010
Last Update
Nov 02
2010
Estimate

Drug Glucophage 500mg

Single Oral Dose of

Drug HL-018 500mg

Single Oral Dose of

Other No administration of Drug

A Active Comparator

Reference

B Experimental

Test

C Placebo Comparator

Placebo

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.
No Results Posted