Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HIP1403; Drug: HGP0919

• Registration Number: NCT02941731
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-19
• Last Update Submitted: 2016-10-19
• Study First Posted: 2016-10-21
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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 29 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.
2. Positive serology for HBs antigen, HCV antibody, HIV antigen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	HGP0919	HGP0919→HIP1403
Sequence 1	HGP0919	HIP1403→HGP0919
Sequence 1	HIP1403	HIP1403→HGP0919
Sequence 2	HIP1403	HGP0919→HIP1403

Primary Outcome Measures

Name	Time	Method
Oseltamivir AUClast , AUCinf	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)
Oseltamivir Cmax	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

Secondary Outcome Measures

Name	Time	Method
Oseltamivir CL/F	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)
Oseltamivir Tmax	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)
Oseltamivir t1/2	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)
Oseltamivir Vd/F	0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

Trial Locations

Locations (1)

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