Evaluating the Bioequivalence of HIP1403, HGP0919

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics of HIP1403 in Healthy Male Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HIP1403; Drug: HGP0919

Detailed Description

A randomized, open-label, single dose, crossover clinical trial to investigate and compare the pharmacokinetics between HIP1403 and HGP0919 in healthy male volunteers.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy male volunteers, age 19 to 45 years.
2. The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
3. 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:

1.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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; HIP1403→HGP0919	Drug: HIP1403; Oseltamivir 75mg; Other Names: Oseltamivir 75mg; Drug: HGP0919; Oseltamivir phosphate 75mg; Other Names: Tamiflu 75mg
Experimental: Sequence 2; HGP0919→HIP1403	Drug: HIP1403; Oseltamivir 75mg; Other Names: Oseltamivir 75mg; Drug: HGP0919; Oseltamivir phosphate 75mg; Other Names: Tamiflu 75mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Oseltamivir Cmax, AUClast , AUCinf	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48hours (Total 16)

Secondary Outcome Measures

Outcome Measure	Time Frame
Oseltamivir Tmax	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48hours (Total 16)
Oseltamivir t1/2	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48hours (Total 16)
Oseltamivir CL/F	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48hours (Total 16)
Oseltamivir Vd/F	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48hours (Total 16)

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Ji Young Park, MD, PhD, Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 14, 2015
• First Submitted That Met QC Criteria: June 14, 2015
• First Posted (Estimate): June 17, 2015

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: HM-OSTA-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO