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Completed

NCT Number: NCT03089112

Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers

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Key information

Conditions

Healthy Male Volunteers

Age range

19 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul Asan Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1.age 19~40 years
  • 2.The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2
  • 3.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

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
  • Subjects who judged ineligible by the investigator

Treatment and study plan

HGP1607

Drug

Take it once per period

HGP1501

Drug

Take it once per period

HGP1607+HGP1501

Drug

Take it once per period

Primary outcomes

  1. AUClast of HGP1607

    Time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h

  2. Cmax of HGP1607

    Time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h

  3. baseline corrected AUClast of HGP1501

    Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

  4. baseline corrected Cmax of HGP1501

    Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Secondary outcomes

  1. AUCinf of HGP1607

    Time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h

  2. Tmax of HGP1607

    Time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h

  3. T1/2 of HGP1607

    Time frame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h

  4. AUClast of HGP1501

    Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

  5. Cmax of HGP1501

    Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

  6. baseline corrected AUCinf of HGP1501

    Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

  7. baseline corrected Tmax of HGP1501

    Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

  8. baseline corrected T1/2 of HGP1501

    Time frame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and the Safety Between HGP1607 and HGP1501 in Healthy Male Volunteers

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2017
Registry last updated
Nov 10, 2022

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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