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

Asan Medical Center

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: No administration of Drug; Drug: Glucophage 500mg; Drug: HL-018 500mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01232036

2010-0195

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Description:

Reference

Treatment:

Drug: Glucophage 500mg

B

Experimental group

Description:

Test

Treatment:

Drug: HL-018 500mg

C

Placebo Comparator group

Description:

Placebo

Treatment:

Other: No administration of Drug