Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

Hypertension Clinical Trial

Official 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02988362
• Other study ID #: HL068
• Status: Not yet recruiting
• Phase: Phase 1
• First received: December 7, 2016
• Last updated: December 8, 2016
• Start date: December 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2016
• Source: HanAll BioPharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• HL068 16/10mg
Candesartan 16mg and Amlodipine 10mg
• Candesartan 16mg and Amlodipine 10mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HanAll BioPharma Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt		up to 72 hours	No
Primary	Cmax		up to 72 hours	No
Secondary	AUCinf		up to 72 hours	No
Secondary	Tmax		up to 72 hours	No
Secondary	t 1/2ß		up to 72 hours	No
Secondary	CL/F		up to 72 hours	No