Investigating the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904

A Randomized, Open Label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904 in Healthy Male Subjects

The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion

Detailed Description

Randomized, open-label, multiple dose , 3-treatment, 6-sequence, 3-period, crossover study, The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

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:

• Healthy male volunteer, age 19~45 years
• The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
• Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

Exclusion Criteria:

• Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
• History of relevant drug allergies or clinically significant hypersensitivity reaction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; A → B → C A: HGP1201 for 9 days B: HGP0904 for 9 days C: HGP1201+ HGP0904 for 9 days	Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion
EXPERIMENTAL: Group 2; C → A → B	Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion
EXPERIMENTAL: Group 3; B → C → A	Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion
EXPERIMENTAL: Group 4; C → B → A	Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion
EXPERIMENTAL: Group 5; B → A → C	Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion
EXPERIMENTAL: Group 6; A → C → B	Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax,ss of HGP1201, HGP0904	1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h
AUCτ,ss of HGP1201, HGP0904	1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: August 24, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (ESTIMATE): September 17, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HM-TARO-101

Plan for Individual participant data (IPD)

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