Investigating the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HGP1201; Drug: HGP0904; Drug: HGP0904 and HGP1201 co-administraion

• Registration Number: NCT02243319
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-08-24
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-17
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	HGP0904 and HGP1201 co-administraion	C → A → B
Group 3	HGP1201	B → C → A
Group 1	HGP1201	A → B → C A: HGP1201 for 9 days B: HGP0904 for 9 days C: HGP1201+ HGP0904 for 9 days
Group 1	HGP0904 and HGP1201 co-administraion	A → B → C A: HGP1201 for 9 days B: HGP0904 for 9 days C: HGP1201+ HGP0904 for 9 days
Group 2	HGP1201	C → A → B
Group 2	HGP0904	C → A → B
Group 3	HGP0904	B → C → A
Group 3	HGP0904 and HGP1201 co-administraion	B → C → A
Group 4	HGP1201	C → B → A
Group 4	HGP0904	C → B → A
Group 4	HGP0904 and HGP1201 co-administraion	C → B → A
Group 5	HGP1201	B → A → C
Group 5	HGP0904	B → A → C
Group 5	HGP0904 and HGP1201 co-administraion	B → A → C
Group 6	HGP1201	A → C → B
Group 6	HGP0904	A → C → B
Group 6	HGP0904 and HGP1201 co-administraion	A → C → B
Group 1	HGP0904	A → B → C A: HGP1201 for 9 days B: HGP0904 for 9 days C: HGP1201+ HGP0904 for 9 days

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of