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Completed

NCT Number: NCT03826641

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1801 in healthy subjects.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University Hospital

Daegu, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 19~45 years in healthy volunteers
  • BMI is more than 18.5 kg/m^2 , no more than 29.9 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

HCP1805

Drug

Dapagliflozin/Metformin (Xigduo XR) 10/1000mg

HCP1801

Drug

Dapagliflozin/Metformin 10/1000mg

Primary outcomes

  1. Cmax of Dapagliflozin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  2. AUClast of Dapagliflozin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  3. Cmax of Metformin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  4. AUClast of Metformin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

Secondary outcomes

  1. AUCinf of Dapagliflozin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  2. Tmax of Dapagliflozin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  3. t1/2 of Dapagliflozin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  4. CL/F of Dapagliflozin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  5. Vd/F of Dapagliflozin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  6. AUCinf of Metformin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  7. Tmax of Metformin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  8. t1/2 of Metformin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  9. CL/F of Metformin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

  10. Vd/F of Metformin

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour

    pharmacokinetic evaluation

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 1, 2019
Registry last updated
Jul 14, 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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