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COMPLETEDPHASE1

Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

An Open-label, Randomized, Cross-over Study to Evaluate Pharmacokinetics and the Safety of HL068 16/10mg Compared to Candesartan 16mg and Amlodipine 10mg Co-administered in Healthy Male Volunteers.

NCT02988362•HanAll BioPharma Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan 16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male volunteers.

Eligibility

Age

19 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male volunteer in the age between 19 and 55 years old.
•Body mass index (BMI) in the range of 18.5 to 27.0 kg/m2
•Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria

•Previous history or present of clinically significant digestive , cardiovascular, respiratory, psychiatric, endocrine, hepatobiliary, renal disease.
•History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
•Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
•Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, ASTor ALT \>1.5 times of the Upper Normal Limit or total bilirubin \> 1.5 times of the Upper Normal Limit
•Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
•Participation in any clinical investigation within 3 months prior to study drug administration
•Subjects with whole blood donation within 60 days or component blood donation within 30days or blood transfusion within 30days prior to the first dosing.
•SBP ≥ 140 mmHg or\< 115 mmHg, DBP ≥ 90 mmHg or \< 70 mmHg
•Caffeine \> 400mg/day
•Alcohol \> 30g/day
+2 more criteria

Key Dates

Start Date

December 14, 2016

Primary Completion Date

February 4, 2017

Completion Date

February 4, 2017

Last Updated

April 4, 2025

Enrollment

ACTUAL participants

Conditions

Hypertension

Interventions

HL068 16/10mg

DRUG

Candesartan 16mg and Amlodipine 10mg

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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