Evaluating the Bioequivalence of HIP1302, HGP1406

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HIP1302; Drug: HGP1406

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

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; HGP1406 → HIP1302	Drug: HIP1302; Tenofovir 292mg; Drug: HGP1406; Tenofovir 300mg
Experimental: Sequence 2; HIP1302 → HGP1406	Drug: HIP1302; Tenofovir 292mg; Drug: HGP1406; Tenofovir 300mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tenofovir Cmax	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
Tenofovir AUClast	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 Outcome Measures

Outcome Measure	Time Frame
Tenofovir Tmax	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
Tenofovir t1/2	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
Tenofovir CL/F	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
Tenofovir AUCinf	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
Tenofovir MRT	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
Tenofovir Vd/F	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Kyung-Sang Yu, M.D., Seoul National University Hospital

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: August 13, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (Estimate): September 10, 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

• Other Study ID Numbers: HM-POVI-101

Plan for Individual participant data (IPD)

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