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

NCT03662620 | Completed Phase 1

• 1 other identifier: YH22162-103
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• AUClast of Telmisartan/amlodipine/chlorthalidone

  AUClast

  0-168 hrs

• Cmax of Telmisartan/amlodipine/chlorthalidone

  Cmax

  0-168 hrs

Secondary Outcomes (3)

• AUCinf of Telmisartan/amlodipine/chlorthalidone

  0-168 hrs

• Tmax of Telmisartan/amlodipine/chlorthalidone

  0-168 hrs

• t1/2 of Telmisartan/amlodipine/chlorthalidone

  0-168 hrs

Study Arms (2)

ARM1

EXPERIMENTAL

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

Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

ARM2

EXPERIMENTAL

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

Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg

Interventions

Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg DRUG

White colored oval three-layer tablet

Also known as: Study drug

ARM1; ARM2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollanam-do, 54907, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Amlodipine; Chlorthalidone; Drug Evaluation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Benzenesulfonamides; Sulfonamides; Amides; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Mingul Kim, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 7, 2018
• Study Start: October 5, 2018
• Primary Completion: December 8, 2018
• Study Completion: December 22, 2018
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)