Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405

A Randomized, Open-label, 4-way Crossover Single Dose Clinical Trial to Investigate the Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 When Administered Alone and in Combination in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02387554

Enrollment

Registered

2015-03-13

Start date

2014-08-31

Completion date

2014-10-31

Last updated

2015-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension(HTN)

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

Interventions

DRUGHGP0904

DRUGHGP0608

DRUGHGP1405

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 19\ 45 years old * Healthy men

Exclusion criteria

* Gastroentestinal disease affecting drug absorption

Design outcomes

Primary

Measure	Time frame	Description
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)
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)

Secondary

Measure	Time frame	Description
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)
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),
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)
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)
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)

Other

Measure	Time frame
Number of Paticipants With Adverse Events	3 months

Countries

South Korea

Participant flow

Participants by arm

Arm	Count
Sequence 1 Period 1 : A Period 2 : L Period 3 : ALC Period 4 : C	10
Sequence 2 Period 1 : L Period 2 : C Period 3 : A Period 4 : ALC	7
Sequence 3 Period 1 : C Period 2 : ALC Period 3 : L Period 4 : A	8
Sequence 4 Period 1 : ALC Period 2 : A Period 3 : C Period 4 : L	8
Total	33

Baseline characteristics

Characteristic	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Total
Age, Continuous	26.70 years STANDARD_DEVIATION 4.06	26.43 years STANDARD_DEVIATION 4.89	26.00 years STANDARD_DEVIATION 3.93	24.88 years STANDARD_DEVIATION 4.05	26.06 years STANDARD_DEVIATION 4.07
Region of Enrollment Korea, Republic of	10 participants	7 participants	8 participants	8 participants	33 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	10 Participants	7 Participants	8 Participants	8 Participants	33 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 28	0 / 27	0 / 27	2 / 28
serious Total, serious adverse events	1 / 28	0 / 27	0 / 27	0 / 28