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

Phase 1

Completed

• Conditions: Hypertension; Hyperlipidemia
• Interventions: Drug: HL040XC; Drug: Losartan + Atorvastatin

• Registration Number: NCT01806324
• Lead Sponsor: HanAll BioPharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-18
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-05
• Last Update Submitted: 2013-03-05
• Study First Posted: 2013-03-07
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HL040XC(Atorvastatin+Losartan)	HL040XC	HL040XC lag time released combination drug
Losartan + Atorvastatin	Losartan + Atorvastatin	Coadministration group

Primary Outcome Measures

Name	Time	Method
Cmax	0 ~ 48hr	To evaluate its bioequivalency in Cmax and AUC of each test group
AUC	0~48HR	To evaluate bioequvalency of each group