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OpenTrials
Completed

NCT Number: NCT02988362

Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

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.

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Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HL068 16/10mg

Drug

Candesartan 16mg and Amlodipine 10mg

Candesartan 16mg and Amlodipine 10mg

Drug

Primary outcomes

  1. AUCt

    Time frame: up to 72 hours

  2. Cmax

    Time frame: up to 72 hours

Secondary outcomes

  1. AUCinf

    Time frame: up to 72 hours

  2. Tmax

    Time frame: up to 72 hours

  3. t 1/2β

    Time frame: up to 72 hours

  4. CL/F

    Time frame: up to 72 hours

Sponsors and collaborators

Lead sponsor

HanAll BioPharma Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2016
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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