Evaluating the Bioequivalence of HIP1302, HGP1406

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HIP1302; Drug: HGP1406

• Registration Number: NCT02545829
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	HGP1406	HGP1406 → HIP1302
Sequence 2	HGP1406	HIP1302 → HGP1406
Sequence 1	HIP1302	HGP1406 → HIP1302
Sequence 2	HIP1302	HIP1302 → HGP1406

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of