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Completed

NCT Number: NCT04081857

A Study to Evaluate the Pharmacokinetics and Safety of HCP1704 in Healthy Subjects

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 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

Metro hospital

Anyang, 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

HGP1810

Drug

HGP1810: Vildagliptin/Metformin

HCP1704

Drug

HCP1704: Vildagliptin/Metformin

Primary outcomes

  1. Cmax of Vildagliptin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  2. AUClast of Vildagliptin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  3. Cmax of Metformin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  4. AUClast of Metformin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

Secondary outcomes

  1. AUCinf of Vildagliptin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  2. Tmax of Vildagliptin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  3. t1/2 of Vildagliptin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  4. CL/F of Vildagliptin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  5. Vd/F of Vildagliptin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  6. AUCinf of Metformin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  7. Tmax of Metformin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  8. t1/2 of Metformin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  9. CL/F of Metformin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour

    pharmacokinetic evaluation

  10. Vd/F of Metformin

    Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 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, Crossover Study to Compare Pharmacokinetic Properties and Safety of HCP1704 and HGP1810 in Healthy Adults

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2019
Registry last updated
Sep 9, 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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