Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: HL068 16/10mg
* Drug: Candesartan 16mg and Amlodipine 10mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candesartan 16mg and Amlodipine 10mg<br>Candesartan 16mg and Amlodipine 10mg | Drug: Candesartan 16mg and Amlodipine 10mg<br> <br> |
| Experimental: HL068<br>HL068(combination of Candesartan 16 mg and Amlodipine 10 mg) | Drug: HL068 16/10mg<br>* Candesartan 16mg and Amlodipine 10mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt |  | up to 72 hours | 
| Cmax |  | up to 72 hours | 

Secondary Outcome Measures

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