Completed

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

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What is being tested

C - V - C+V

+ V - C - C+V

+ V - C+V - C

Drug
Who is being recruted

From 20 to 40 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorIlDong Pharmaceutical Co Ltd
Last updated: October 14, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01838967
Principal SponsorIlDong Pharmaceutical Co Ltd
Last updated: October 14, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 20 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening
Healthy male volunteers, age 20 to 40 years
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
Subjects who have no congenital or chronic disease and no abnormal symptom or opinion
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13 exclusion criteria prevent from participating
A subject who takes St John's wort or some food including the ingredient within 14 days prior to the participation of the study
A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 3 days prior to the participation of the study
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
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 II

Experimental
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 III

Experimental
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 IV

Experimental
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 5

Experimental
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 6

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Seoul National University Hospital

Jongno-gu, South KoreaOpen Seoul National University Hospital in Google Maps
CompletedOne Study Center