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Completed

NCT Number: NCT04087525

A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 in Healthy Subjects

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HIP1701 in healthy subjects.

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Key information

Conditions

Health, Subjective

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 19~55 years in healthy volunteers
  • BMI is more than 18.5 kg/m^2 , no more than 24.9 kg/m^2
  • 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

HIP1701

Drug

Vildagliptin

HGP1809

Drug

Vildagliptin

Primary outcomes

  1. Cmax of Vildagliptin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

    pharmacokinetic evaluation

  2. AUClast of Vildagliptin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

    pharmacokinetic evaluation

Secondary outcomes

  1. AUCinf of Vildagliptin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

    pharmacokinetic evaluation

  2. Tmax of Vildagliptin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

    pharmacokinetic evaluation

  3. t1/2 of Vildagliptin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

    pharmacokinetic evaluation

  4. CL/F of Vildagliptin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

    pharmacokinetic evaluation

  5. Vd/F of Vildagliptin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

    pharmacokinetic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Open-Label, Single-Dose, Two-way Crossover Study to Compare Pharmacokinetic Properties and Safety of HIP1701 and HGP1809 in Healthy Adults

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2019
Registry last updated
Sep 12, 2019

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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