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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02988362

Enrollment

Registered

2016-12-09

Start date

2016-12-14

Completion date

2017-02-04

Last updated

2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief 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.

Interventions

DRUGHL068 16/10mg

Candesartan 16mg and Amlodipine 10mg

DRUGCandesartan 16mg and Amlodipine 10mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
AUCt	up to 72 hours
Cmax	up to 72 hours

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026