Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects

A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects

This study is designated to evaluate the pharmacokinetic interactions of amlodipine besylate, valsartan and rosuvastatin in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Deagu, Korea, Republic of
    • Kyungpook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male volunteers in the age between 20 and 55 years old
2. The weight range is not exceed ±20% of ideal weight Ideal weight = [height -100]*0.9
3. Subjects with no history of any significant chronic disease
4. Judged to be in good health on the basis of their electrocardiography (ECG) and routine laboratory data obtained within 3 weeks prior to study drug administration
5. Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

1. History of clinically significant allergies including drug allergies
2. History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
3. History of genetic muscular disease and family history
4. hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100)
5. AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( > 1.5 times to normal range
6. Creatinine clearance < 80mL/min
7. Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
8. Serious injury, surgery and acute illness within 4 weeks prior to drug administration

9. History of alcohol, smoking abuse

   • alcohol > 21 units/week, 1 unit=10g=12.5mL of pure alcohol
   • smoking > 10 cigarettes/day
10. Use of any other medication, including herbal products, within the 2 weeks before dosing
11. Participated in a previous clinical trial within 3 months prior to drug administration
12. Subjects with whole blood donation within 2 months, component blood donation within months prior to drug administration
13. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
14. Clinical laboratory test values are positive (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
15. Subjects considered as unsuitable based on medical judgement by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exforge 10/160mg(amlodipine 10mg, valsartan160mg); 1 tablet daily for 10days	Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.
Experimental: crestor 20mg(rosuvastatin 20mg); 1 tablet daily for 7days	Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the drug-drug interactions of amlodipine, valsartan and rosuvastatin: Cmax,ss(Maximum steady-state plasma drug concentration during a dosage interval ), AUCτ(Area Under the Curve)	after steady state (Administration of Investigational Product 7day or 10days)	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2	steady state (Administration of Investigational Product)	3 days

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Young Ran Yoon PhD, Kyungpook university hostipal

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 9, 2014
• First Posted (Estimate): February 11, 2014

Study Record Updates

• Last Update Posted (Estimate): December 29, 2016
• Last Update Submitted That Met QC Criteria: December 28, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; Pharmacodynamics
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Amlodipine, Valsartan Drug Combination
• Other Study ID Numbers: CJ_EXR_101