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Completed

NCT Number: NCT01232036

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

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

Completed

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucophage 500mg

Drug

Single Oral Dose of

HL-018 500mg

Drug

Single Oral Dose of

No administration of Drug

Other

Primary outcomes

  1. Pharmacokinetics (AUClast and Cmax)

    Time frame: 24hours

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • HanAll BioPharma Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 2, 2010
Registry last updated
Nov 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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