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Completed

NCT Number: NCT02941731

Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions

The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 suspensions in healthy male volunteers.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam Hospital

Seoul, South Korea

About this study

A randomized, open-label, single dose, crossover clinical trial to investigate and compare the pharmacokinetics between HIP1403 and HGP0919 suspensions 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 volunteers, age 19 to 45 years.
  • The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 29 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.
  • Positive serology for HBs antigen, HCV antibody, HIV antigen

Treatment and study plan

HIP1403

Drug

Oseltamivir 6mg/mL

Other names: Oseltamivir 6mg/mL

HGP0919

Drug

Oseltamivir phosphate 6mg/mL

Other names: Tamiflu Oral Suspension 6mg/mL

Primary outcomes

  1. Oseltamivir Cmax

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

  2. Oseltamivir AUClast , AUCinf

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

Secondary outcomes

  1. Oseltamivir Tmax

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

  2. Oseltamivir t1/2

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

  3. Oseltamivir CL/F

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

  4. Oseltamivir Vd/F

    Time frame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

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 of HIP1403 in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2016
Registry last updated
Oct 21, 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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