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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01806324
• Date of registration: 18/04/2012
• Prospective Registration: No
• Primary sponsor: HanAll BioPharma Co., Ltd.
• Public title: A Study to Evaluate Pharmacokinetics and Potential Drug Interactions of a Fixed-dose Combination Tablet, HL-040XC, in Healthy Male Subjects
• Date of first enrolment: April 2012
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01806324
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

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.



Age minimum: 19 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Hyperlipidemia

Hypertension

Intervention(s)

Drug: HL040XC

Drug: Losartan + Atorvastatin

Primary Outcome(s)

Cmax [Time Frame: 0 ~ 48hr]

AUC [Time Frame: 0~48HR]

Secondary ID(s)

HL-040XC-US-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors