A Drug Interaction Study of Cilnidipine and Valsartan

NCT ID: NCT01838967

Last Updated: 2013-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-10-31

Brief Summary

The investigators investigate the potential pharmacokinetic drug-drug interaction between Cilnidipine 10 mg and Valsartan 160 mg in healthy male volunteers who receive Cilnidipine 10 mg alone, Valsartan 160 mg , and both together in a 3 period repeatedly.

Detailed Description

To evaluate the safety, drug-tolerance, pharmacokinetics of Cilnidipine 10 mg or Valsartan 160 mg monotherapy or Cilnidipine 10 mg and Valsartan 160 mg combination in healthy male subjects.

Conditions

Healthy

Keywords

cilnidipin and valsartn; pharmacokinetic drug drug interaction; oral administration; healthy male subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C - V - C+V

C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time

Group Type: EXPERIMENTAL

C - V - C+V

Intervention Type: DRUG

Drug will be administered to according to C - V - C+V sequence for 3 period.

V - C - C+V

C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time

Group Type: EXPERIMENTAL

V - C - C+V

Intervention Type: DRUG

Drug will be administered to according to V - C - C+V sequence for 3 period.

V - C+V - C

C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time

Group Type: EXPERIMENTAL

V - C+V - C

Intervention Type: DRUG

Drug will be administered to according to V - C+V - C sequence for 3 period.

C+V - V - C

C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time

Group Type: EXPERIMENTAL

C+V - C - V

Intervention Type: DRUG

Drug will be administered to according to C+V - C - V sequence for 3 period.

C+V - C - V

C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time

Group Type: EXPERIMENTAL

C+V - V - C

Intervention Type: DRUG

Drug will be administered to according to C+V - V - C sequence for 3 period.

C - C+V - V

C - Cilnidipine 10mg will be administered orally only one time. V - Valsartan 160mg will be administered orally only one time. C+V - Cilnidipine 10mg plus Valsartan 160mg will be administered orally only one time

Group Type: EXPERIMENTAL

C - C+V - V

Intervention Type: DRUG

Drug will be administered to according to C - C+V - V sequence for 3 period.

Interventions

C - V - C+V

Drug will be administered to according to C - V - C+V sequence for 3 period.

Intervention Type: DRUG

C - C+V - V

Drug will be administered to according to C - C+V - V sequence for 3 period.

Intervention Type: DRUG

V - C - C+V

Drug will be administered to according to V - C - C+V sequence for 3 period.

Intervention Type: DRUG

V - C+V - C

Drug will be administered to according to V - C+V - C sequence for 3 period.

Intervention Type: DRUG

C+V - C - V

Drug will be administered to according to C+V - C - V sequence for 3 period.

Intervention Type: DRUG

C+V - V - C

Drug will be administered to according to C+V - V - C sequence for 3 period.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male volunteers, age 20 to 40 years

2. The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 25 kg/m2 and body weight are least 55 kg

3. Subjects who have no congenital or chronic disease and no abnormal symptom or opinion

4. Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening

5. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria

1. A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease

2. A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug

3. A subject with history of drug allergies (aspirin, antibiotics, including study drug etc.), or history of clinically significant allergies

4. Systolic blood pressure <100mmHg or Diastolic blood pressure < 60 mmHg, systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100mmHg(Sitting blood pressure) during the screening procedure.

5. Presence or history of drug abuse or positive result in urine drug screening test

6. Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)

7. Participation in clinical trials of any drug within 60 days prior to the participation of the study

8. Blood donation during 2 months or apheresis during 1 month before the study

9. Use of alcohol over 21 units/weeks

10. Smoker who smoke more than 20 cigarettes per day

11. A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 3 days prior to the participation of the study

12. A subject who takes St John's wort or some food including the ingredient within 14 days prior to the participation of the study

13. Judged to be inappropriate for the study by the investigator after reviewing clinical laboratory results or other reasons.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyoung Sang You, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Jongno-gu, Seoul, South Korea

Countries

South Korea

Other Identifiers

ID_IDCV_1301

Identifier Type: -

Identifier Source: org_study_id