A Drug Interaction Study of Cilnidipine and Valsartan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier:
NCT01838967
First received: April 16, 2013
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: C - V - C+V
Drug: C - C+V - V
Drug: V - C - C+V
Drug: V - C+V - C
Drug: C+V - C - V
Drug: C+V - V - C
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Cilnidipine 10 mg and Valsartan 160 mg After Oral Administration in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by IlDong Pharmaceutical Co Ltd:

Primary Outcome Measures:
  • Cmax of Cilnidipine 10 mg [ Time Frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose ] [ Designated as safety issue: No ]
  • Cmax of Valsartan 160 mg [ Time Frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose ] [ Designated as safety issue: No ]
  • AUClast of Cilnidipine 10 mg [ Time Frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose ] [ Designated as safety issue: No ]
  • AUClast of Valsartan 160 mg [ Time Frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax of Cilnidipine 10 mg [ Time Frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose ] [ Designated as safety issue: No ]
  • Tmax of Valsartan 160 mg [ Time Frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose ] [ Designated as safety issue: No ]
  • AUCinf of Cilnidipine 10 mg [ Time Frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose ] [ Designated as safety issue: No ]
  • CL/F of Cilnidipine 10 mg [ Time Frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose ] [ Designated as safety issue: No ]
  • AUCinf of Valsartan 160 mg [ Time Frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose ] [ Designated as safety issue: No ]
  • CL/F of Valsartan 160 mg [ Time Frame: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: April 2013
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: C - V - C+V
Drug will be administered to according to C - V - C+V sequence for 3 period.
Experimental: 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
Drug: V - C - C+V
Drug will be administered to according to V - C - C+V sequence for 3 period.
Experimental: 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
Drug: V - C+V - C
Drug will be administered to according to V - C+V - C sequence for 3 period.
Experimental: 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
Drug: C+V - C - V
Drug will be administered to according to C+V - C - V sequence for 3 period.
Experimental: 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
Drug: C+V - V - C
Drug will be administered to according to C+V - V - C sequence for 3 period.
Experimental: 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
Drug: C - C+V - V
Drug will be administered to according to C - C+V - V sequence for 3 period.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01838967

Locations
Korea, Republic of
Seoul National University Hospital
Jongno-gu, Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
Investigators
Principal Investigator: Kyoung Sang You, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT01838967     History of Changes
Other Study ID Numbers: ID_IDCV_1301
Study First Received: April 16, 2013
Last Updated: October 11, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by IlDong Pharmaceutical Co Ltd:
cilnidipin and valsartn
pharmacokinetic drug drug interaction
oral administration
healthy male subjects

Additional relevant MeSH terms:
Cilnidipine
Valsartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 21, 2014