Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin

A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03116516

Enrollment

Registered

2017-04-17

Start date

2017-04-21

Completion date

2017-05-26

Last updated

2019-01-16

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

Conditions

Hyperlipidemia, Hypertension

Brief summary

This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers Hypothesis: YHP1604 and telmisartan/amlodipine and rosuvastatin are showing equal pharmacokinetics.

Detailed description

This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers. In ARM1, 30 subjects will be assigned and the subjects will be administered telmisartan/amlodipine and rosuvastatin at Day1 and YHP1604 at Day22. In ARM2, 30 subjects will be assigned and the subjects will be administered YHP1604 at Day1 and telmisartan/amlodipine and rosuvastatin at Day22.

Interventions

DRUGTemisartan/Amlodipine+Rosuvastatin

All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.

DRUGYHP1604

All subjects will receive a single oral dose of YHP1604 administered in the morning.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A randomized, open-label, single dose, crossover clinical trial

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2 * Who has not suffered from clinically significant disease * Provision of signed written informed consent

Exclusion criteria

* History of and clinically significant disease * A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs * Administration of other investigational products within 3 months prior to the first dosing * Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Design outcomes

Primary

Measure	Time frame	Description
Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast	0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs	Cmax, AUClast

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026