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

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806324
• Other study ID #: HL-040XC-US-001
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2012
• Last updated: March 5, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: HanAll BioPharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Healthy male subjects between 19 and 50 years of age, inclusive.

2. 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.

3. Subjects who don't have any congenital or chronic disease.

4. Subjects who don't have any clinically significant abnormality on vital sign measurement, physical examination, clinical lab test, and ECG test at Screening.

5. Subjects who are able to read and understand the consent form.

Exclusion Criteria:

1. Subjects who have any history or presence of hypersensitivity to HMG-CoA reductase inhibitors such as atorvastatin or angiotensin receptor blockers such as losartan.

2. 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).

3. 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).

4. Subjects who had a severe injury or surgery within 4 weeks prior to Screening.

5. Subjects who have a positive drug screen.

6. Subjects who take any prescription or herbal drug within 1 week prior to Screening.

7. 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.

8. 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.

9. 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).

10. Subjects who received an investigational product within 4 weeks prior to Screening.

11. Subjects who have donated blood within 6 weeks prior to Screening.

12. 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.

13. Subjects who smoke more than 10 cigarettes per day.

14. 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.

15. Subjects who test positive on serology HBsAg, HCV Ab, HIV Ab or VDRL at Screening.

16. Subjects who have active liver disease or elevated serum transaminase level higher than 3 times of upper limit of normal.

17. Subjects who have the inability in the opinion of the investigator to comply with the protocol.

Study Design

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Drug:
• HL040XC
single dose
• Losartan + Atorvastatin
Single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HanAll BioPharma Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	To evaluate its bioequivalency in Cmax and AUC of each test group	0 ~ 48hr	Yes
Primary	AUC	To evaluate bioequvalency of each group	0~48HR