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Completed

NCT Number: NCT02545829

Evaluating the Bioequivalence of HIP1302, HGP1406

The purpose of this study is to investigate the bioequivalence after administration of HIP1302 and HGP1406 in healthy male volunteers.

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

A Randomized, Open, 2-way cross-over, Single dose study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 in Healthy Korean Male Volunteers

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers, age 19 to 50 years
  • The result of Body Mass Index(BMI) is not less than 18.0 kg/m2, no more than 27.0 kg/m2
  • 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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.

Treatment and study plan

HIP1302

Drug

Tenofovir 292mg

HGP1406

Drug

Tenofovir 300mg

Primary outcomes

  1. Tenofovir Cmax

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  2. Tenofovir AUClast

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

Secondary outcomes

  1. Tenofovir Tmax

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  2. Tenofovir t1/2

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  3. Tenofovir CL/F

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  4. Tenofovir AUCinf

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  5. Tenofovir MRT

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  6. Tenofovir Vd/F

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Open, 2-way Cross-over, Single Dose Study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 (Tenofovir) in Healthy Korean Male Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2015
Registry last updated
Oct 13, 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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