Clinical trial NCT02060019: Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
Official title: A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Pharmacodynamics
Safety
Tolerability
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2014-02-11
Enrollment: 57
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 3 days
Secondary outcomes:
measure: Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2
timeFrame: 3 days
Other outcomes:
Locations:
city: Deagu
country: Korea, Republic of
facility: Kyungpook university hospital
Study officials:
affiliation: Kyungpook university hostipal
name: Young Ran Yoon PhD
role: PRINCIPAL_INVESTIGATOR
References: