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

Phase 1

Completed

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

• Registration Number: NCT02060019
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-09
• Study First Posted: 2014-02-11
• Study Start: 2014-03
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
crestor 20mg(rosuvastatin 20mg)	administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.	1 tablet daily for 7days
exforge 10/160mg(amlodipine 10mg, valsartan160mg)	administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.	1 tablet daily for 10days

Primary Outcome Measures

Name	Time	Method
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)	3 days	after steady state (Administration of Investigational Product 7day or 10days)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyungpook university hospital; 🇰🇷 Deagu, Korea, Republic of