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

NCT02060019 | Completed Phase 1

• 1 other identifier: CJ_EXR_101
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Pharmacokinetics; Pharmacodynamics; Safety; Tolerability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of the amlodipine, valsartan and rosuvastatin : AUCinf, tmax,ss(Time to reach Cmax,ss), t1/2

  3 days

Study Arms (2)

exforge 10/160mg(amlodipine 10mg, valsartan160mg)

EXPERIMENTAL

1 tablet daily for 10days

Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.

crestor 20mg(rosuvastatin 20mg)

EXPERIMENTAL

1 tablet daily for 7days

Drug: administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.

Interventions

administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg. DRUG

crestor 20mg(rosuvastatin 20mg); exforge 10/160mg(amlodipine 10mg, valsartan160mg)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male volunteers in the age between 20 and 55 years old
• The weight range is not exceed ±20% of ideal weight Ideal weight = \[height -100\]\*0.9
• Subjects with no history of any significant chronic disease
• 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
• Willing to adhere to protocol requirements and sign a informed consent form

You may not qualify if:

• History of clinically significant allergies including drug allergies
• History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
• History of genetic muscular disease and family history
• hypotension (Systolic Blood Pressure(SBP) ≤ 105 or Diastolic Blood Pressure(DBP) ≤ 65) or hypertension(SBP ≥ 150 or DBP ≥ 100)
• AST(Aspartate Transaminase), ALT(ALanine Transaminase), total bilirubin( \> 1.5 times to normal range
• Creatinine clearance \< 80mL/min
• Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines
• Serious injury, surgery and acute illness within 4 weeks prior to drug administration
• History of alcohol, smoking abuse
• alcohol \> 21 units/week, 1 unit=10g=12.5mL of pure alcohol
• smoking \> 10 cigarettes/day
• Use of any other medication, including herbal products, within the 2 weeks before dosing
• Participated in a previous clinical trial within 3 months prior to drug administration
• Subjects with whole blood donation within 2 months, component blood donation within months prior to drug administration
• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Kyungpook university hospital

Deagu, South Korea

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Young Ran Yoon PhD

  Kyungpook university hostipal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 11, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

KR (1)