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Completed

NCT Number: NCT02712411

Pharmacokinetics and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 in Healthy Male Volunteers

To investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 in healthy male volunteers

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Key information

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yonsei University Health System, Severance Hospital

Seodaemun-Gu, Seoul, 03722, South Korea

About this study

The purpose of this study is to investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 in healthy male volunteers

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteer, age 20~55 years
  • The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
  • Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
  • Subject who has the ability and willingness to participate the whole period of trial

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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  • History of relevant drug allergies or clinically significant hypersensitivity reaction.
  • Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
  • Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
  • SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower thatn 60mmHg or higher than 100mmHg
  • Subjects who judged ineligible by the investigator.

Treatment and study plan

HCP1303

Drug

HGP1201

Drug

HIP1402

Drug

Primary outcomes

  1. AUClast

    Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

  2. Cmax

    Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

Secondary outcomes

  1. AUCinf

    Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

  2. tmax

    Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

  3. t1/2

    Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

  4. Cl/F

    Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

  5. Vd/F

    Time frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Open-Label, Crossover, Single-Dose Study to Compare Pharmacokinetic Properties and Safety After Administration of HCP1303 Capsule and Co-administration of HGP1201 Tablet, HIP1402 Capsule in Healthy Male Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2016
Registry last updated
Mar 18, 2016

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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