Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-05

Study Completion Date

2018-12-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers.

Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy & Safety Study of YH22162 vs Telmisartan/Amlodipine in Patients With Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment

NCT02620163

Hypertension

COMPLETED PHASE3

PK Study of YH22162 FDC Compared to Combination of Twynsta and Hygroton

NCT02496910

Hypertension

COMPLETED PHASE1

Clinical Trial to Compare the Pharmacokinetics of TAH Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers

NCT02739672

Healthy

COMPLETED PHASE1

Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension

NCT06041529

Essential Hypertension

RECRUITING PHASE4

PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin

NCT02608242

Hypertension Hyperlipidemia

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.

In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, open-label, single-dose, 2-treatment, 2-sequence, 4-period replicate crossover design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARM1

In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.

Group Type EXPERIMENTAL

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

Intervention Type DRUG

White colored oval three-layer tablet

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

Intervention Type DRUG

White and pink colored oval two-layer tablet

ARM2

In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.

Group Type EXPERIMENTAL

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

Intervention Type DRUG

White colored oval three-layer tablet

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

Intervention Type DRUG

White and pink colored oval two-layer tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

White colored oval three-layer tablet

Intervention Type DRUG

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

White and pink colored oval two-layer tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Study drug Comparator drug

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes