Completed
A Study to Evaluate Pharmacokinetics and Potential Drug Interactions of a Fixed-dose Combination Tablet, HL-040XC, in Healthy Male Subjects
What is being tested
HL040XC
+ Losartan + Atorvastatin
Drug
Who is being recruted
Cardiovascular Diseases+5
+ Metabolic Diseases
+ Nutritional and Metabolic Diseases
From 19 to 50 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: April 2012
Summary
Principal SponsorHanAll BioPharma Co., Ltd.
Last updated: March 7, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2012
Actual date on which the first participant was enrolled.The objective of this study is: To evaluate the pharmacokinetics and safety of an experimental combination tablet containing 20 mg atorvastatin and 50 mg losartan potassium when administered orally as a single dose to healthy male subjects, compared with the concomitant administration of 20 mg atorvastatin and 50 mg losartan potassium tablets.
Principal SponsorHanAll BioPharma Co., Ltd.
Last updated: March 7, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.From 19 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesDyslipidemiasLipid Metabolism DisordersHyperlipidemiasHypertension
Criteria
5 inclusion criteria required to participate
Healthy male subjects between 19 and 50 years of age, inclusive
Subjects who are able to read and understand the consent form
Subjects who don't have any clinically significant abnormality on vital sign measurement, physical examination, clinical lab test, and ECG test at Screening
Subjects who don't have any congenital or chronic disease
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17 exclusion criteria prevent from participating
Subjects who consume alcohol over 21 units per week (1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol) and can't accept the prohibition of alcohol during this clinical study
Subjects who had a severe injury or surgery within 4 weeks prior to Screening
Subjects who have a creatinine clearance < 80 mL/min, which is calculated by Cockcroft-Gault equation: (140 - age) x (Wt in kg) / (72 x sCr)
Subjects who have a positive drug screen
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalHL040XC lag time released combination drug
Group II
Active ComparatorCoadministration group
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Baltimore, United StatesOpen in Google Maps
CompletedOne Study Center