Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

December 8, 2016 updated by: HanAll BioPharma Co., Ltd.

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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
  • Cigarette > 10 cigarettes/day.
  • Subjects who are judged unsuitable by investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Candesartan 16mg and Amlodipine 10mg
Drug: Candesartan 16mg and Amlodipine 10mg
EXPERIMENTAL: HL068
HL068(combination of Candesartan 16 mg and Amlodipine 10 mg)
Drug: HL068 16/10mg
Candesartan 16mg and Amlodipine 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax
Time Frame: up to 72 hours
up to 72 hours
AUCt
Time Frame: up to 72 hours
up to 72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Tmax
Time Frame: up to 72 hours
up to 72 hours
AUCinf
Time Frame: up to 72 hours
up to 72 hours
CL/F
Time Frame: up to 72 hours
up to 72 hours
t 1/2β
Time Frame: up to 72 hours
up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HanAll BioPharma Co., Ltd.

Investigators

  • Principal Investigator: Young-Ran Yoon, M.D, Ph.D, Kyungpook National University Hospital Clinical Trial Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

February 1, 2017

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (ESTIMATE)

December 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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