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Evaluating the Bioequivalence of HIP1403, HGP0919

Information source: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza A,B

Intervention: HIP1403 (Drug); HGP0919 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hanmi Pharmaceutical Company Limited

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Oseltamivir Cmax

Oseltamivir AUClast , AUCinf

Secondary outcome:

Oseltamivir Tmax

Oseltamivir t1/2

Oseltamivir CL/F

Oseltamivir Vd/F

Eligibility

Minimum age: 19 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Korea University Anam Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: April 2015
Last updated: June 14, 2015

Page last updated: August 23, 2015

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