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A Study to Evaluate Pharmacokinetics and Potential Drug Interactions of a Fixed-dose Combination Tablet, HL-040XC, in Healthy Male Subjects

Primary Purpose

Hypertension, Hyperlipidemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

HL040XC

Losartan + Atorvastatin

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male subjects between 19 and 50 years of age, inclusive.
Subjects who weigh at least 121 pounds (55 kg), and are within ± 20% of their of ideal body weight (IBW). IBW (kg) = [height (cm) - 100] x 0.9.
Subjects who don't have any congenital or chronic disease.
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 are able to read and understand the consent form.

Exclusion Criteria:

Subjects who have any history or presence of hypersensitivity to HMG-CoA reductase inhibitors such as atorvastatin or angiotensin receptor blockers such as losartan.
Subjects who have any medical history that may affect the absorption, distribution, metabolism, and excretion of study drugs (e.g., cardiovascular, respiratory, renal, endocrinal, hematological, digestive, neurological, or psychiatric disease).
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 had a severe injury or surgery within 4 weeks prior to Screening.
Subjects who have a positive drug screen.
Subjects who take any prescription or herbal drug within 1 week prior to Screening.
Subjects who take any over-the counter (OTC) drug, which may affect this study or the subject's safety according to the judgment of investigator, at Screening.
Subjects who take any herbal drug containing St. John's Wort or other drugs, which are metabolized by CYP3A4 enzyme or inhibit or stimulate CYP enzyme (e.g., itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitor, nefazodone) within 4 weeks prior to Screening.
Subjects who have abnormal meal pattern that may affect the absorption, distribution, metabolism, and excretion of study drugs (e.g., taking grapefruit juice over 1 L per day).
Subjects who received an investigational product within 4 weeks prior to Screening.
Subjects who have donated blood within 6 weeks prior to Screening.
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 smoke more than 10 cigarettes per day.
Subjects who have low blood pressure (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or high blood pressure (systolic ≥ 150 mmHg or diastolic ≥ 95 mmHg) at Screening.
Subjects who test positive on serology HBsAg, HCV Ab, HIV Ab or VDRL at Screening.
Subjects who have active liver disease or elevated serum transaminase level higher than 3 times of upper limit of normal.
Subjects who have the inability in the opinion of the investigator to comply with the protocol.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HL040XC(Atorvastatin+Losartan)

Losartan + Atorvastatin

Arm Description

HL040XC lag time released combination drug

Coadministration group

Outcomes

Primary Outcome Measures

Cmax

To evaluate its bioequivalency in Cmax and AUC of each test group

AUC

To evaluate bioequvalency of each group

Secondary Outcome Measures

Full Information

NCT ID

NCT01806324

First Posted

April 18, 2012

Last Updated

March 5, 2013

Sponsor

HanAll BioPharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01806324

Brief Title

A Study to Evaluate Pharmacokinetics and Potential Drug Interactions of a Fixed-dose Combination Tablet, HL-040XC, in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HanAll BioPharma Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HL040XC(Atorvastatin+Losartan)

Arm Type

Experimental

Arm Description

HL040XC lag time released combination drug

Arm Title

Losartan + Atorvastatin

Arm Type

Active Comparator

Arm Description

Coadministration group

Intervention Type

Drug

Intervention Name(s)

HL040XC

Intervention Description

single dose

Intervention Type

Drug

Intervention Name(s)

Losartan + Atorvastatin

Intervention Description

Single dose

Primary Outcome Measure Information:

Title

Cmax

Description

To evaluate its bioequivalency in Cmax and AUC of each test group

Time Frame

0 ~ 48hr

Title

AUC

Description

To evaluate bioequvalency of each group

Time Frame

0~48HR

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male subjects between 19 and 50 years of age, inclusive. Subjects who weigh at least 121 pounds (55 kg), and are within ± 20% of their of ideal body weight (IBW). IBW (kg) = [height (cm) - 100] x 0.9. Subjects who don't have any congenital or chronic disease. 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 are able to read and understand the consent form. Exclusion Criteria: Subjects who have any history or presence of hypersensitivity to HMG-CoA reductase inhibitors such as atorvastatin or angiotensin receptor blockers such as losartan. Subjects who have any medical history that may affect the absorption, distribution, metabolism, and excretion of study drugs (e.g., cardiovascular, respiratory, renal, endocrinal, hematological, digestive, neurological, or psychiatric disease). 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 had a severe injury or surgery within 4 weeks prior to Screening. Subjects who have a positive drug screen. Subjects who take any prescription or herbal drug within 1 week prior to Screening. Subjects who take any over-the counter (OTC) drug, which may affect this study or the subject's safety according to the judgment of investigator, at Screening. Subjects who take any herbal drug containing St. John's Wort or other drugs, which are metabolized by CYP3A4 enzyme or inhibit or stimulate CYP enzyme (e.g., itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitor, nefazodone) within 4 weeks prior to Screening. Subjects who have abnormal meal pattern that may affect the absorption, distribution, metabolism, and excretion of study drugs (e.g., taking grapefruit juice over 1 L per day). Subjects who received an investigational product within 4 weeks prior to Screening. Subjects who have donated blood within 6 weeks prior to Screening. 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 smoke more than 10 cigarettes per day. Subjects who have low blood pressure (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or high blood pressure (systolic ≥ 150 mmHg or diastolic ≥ 95 mmHg) at Screening. Subjects who test positive on serology HBsAg, HCV Ab, HIV Ab or VDRL at Screening. Subjects who have active liver disease or elevated serum transaminase level higher than 3 times of upper limit of normal. Subjects who have the inability in the opinion of the investigator to comply with the protocol.

Facility Information:

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate Pharmacokinetics and Potential Drug Interactions of a Fixed-dose Combination Tablet, HL-040XC, in Healthy Male Subjects

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