Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405

Phase 1

Completed

• Conditions: Hypertension(HTN)
• Interventions: Drug: HGP0904; Drug: HGP0608; Drug: HGP1405

• Registration Number: NCT02387554
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-13
• Status Verified: 2015-05
• Results First Submitted: 2015-05-22
• Results First Submitted QC: 2015-06-11
• Last Update Submitted: 2015-06-11
• Results First Posted: 2015-06-12
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

Inclusion Criteria

• 19~45 years old
• Healthy men

Exclusion Criteria

• Gastroentestinal disease affecting drug absorption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HGP0904+HGP0608+HGP1405	HGP0904	amlodipine + losartan + chlorthalidone
HGP0904+HGP0608+HGP1405	HGP1405	amlodipine + losartan + chlorthalidone
HGP0904+HGP0608+HGP1405	HGP0608	amlodipine + losartan + chlorthalidone
HGP0904	HGP0904	amlodipine
HGP0608	HGP0608	losartan
HGP1405	HGP1405	chlorthalidone

Primary Outcome Measures

Name	Time	Method
AUClast	0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr	AUClast(Area under the curve to the last measurable concentration)
Cmax	0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr	Cmax(maxium concentration)

Secondary Outcome Measures

Name	Time	Method
Vz/F	0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr	Vz/F(Apparent volume of distribution)
Tmax	0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr	Tmax(Time to maximum concentration)
AUCinf	0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr	AUCinf(Area under the curve to infinity)
CL/F	0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr	CL/F(Apparent clearance)
T1/2	0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr	T1/2(Terminal elimination half-life),

Trial Locations

Locations (1)

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