HealthyPhase 1NCT01838967
A Drug Interaction Study of Cilnidipine and Valsartan
A Phase 1 study testing C - V - C+V, C - C+V - V and V - C - C+V in people with Healthy, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- C - V - C+V, C - C+V - V and V - C - C+V
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, age 20 to 40 years
- 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
- Subjects who have no congenital or chronic disease and no abnormal symptom or opinion
- Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening
- 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
Who cannot join
- 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
- 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 history of drug allergies (aspirin, antibiotics, including study drug etc.), or history of clinically significant allergies
- 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.
- Presence or history of drug abuse or positive result in urine drug screening test
- 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)
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- Participation in clinical trials of any drug within 60 days prior to the participation of the study
- Blood donation during 2 months or apheresis during 1 month before the study
- Use of alcohol over 21 units/weeks
- Smoker who smoke more than 20 cigarettes per day
- A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 3 days prior to the participation of the study
- A subject who takes St John's wort or some food including the ingredient within 14 days prior to the participation of the study
- Judged to be inappropriate for the study by the investigator after reviewing clinical laboratory results or other reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Jongno-gu, Seoul, 110-744
About this study
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
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.
Read the 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
- Being tested
- C - V - C+V, C - C+V - V, V - C - C+V, V - C+V - C, C+V - C - V
- Keywords
- cilnidipin and valsartn, pharmacokinetic drug drug interaction, oral administration, healthy male subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C - V - C+VDrug
Drug will be administered to according to C - V - C+V sequence for 3 period.
C - C+V - VDrug
Drug will be administered to according to C - C+V - V sequence for 3 period.
V - C - C+VDrug
Drug will be administered to according to V - C - C+V sequence for 3 period.
V - C+V - CDrug
Drug will be administered to according to V - C+V - C sequence for 3 period.
C+V - C - VDrug
Drug will be administered to according to C+V - C - V sequence for 3 period.
C+V - V - CDrug
Drug will be administered to according to C+V - V - C sequence for 3 period.
| Study group | Role | What they receive |
|---|---|---|
| C - V - C+V | 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 Receives: Drug: C - V - C+V |
| V - C - C+V | 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 Receives: Drug: V - C - C+V |
| V - C+V - C | 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 Receives: Drug: V - C+V - C |
| C+V - V - C | 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 Receives: Drug: C+V - C - V |
| C+V - C - V | 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 Receives: Drug: C+V - V - C |
| C - C+V - V | 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 Receives: Drug: C - C+V - V |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Cilnidipine 10 mg
Measured: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
Cmax of Valsartan 160 mg
Measured: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
AUClast of Cilnidipine 10 mg
Measured: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
AUClast of Valsartan 160 mg
Measured: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
Secondary outcomes (6)
Tmax of Cilnidipine 10 mg
Measured: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
Tmax of Valsartan 160 mg
Measured: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
AUCinf of Cilnidipine 10 mg
Measured: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
CL/F of Cilnidipine 10 mg
Measured: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
AUCinf of Valsartan 160 mg
Measured: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
CL/F of Valsartan 160 mg
Measured: 1d(8d, 15d) pre-dose, 0.5, 1, 2, 2.5, 3, 4, 5, 6, 8, 12, 24h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyoung Sang You, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838967
- Sponsor's protocol ID
- ID_IDCV_1301
- Status last verified
- Oct 2013
- First submitted
- 16 Apr 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01838967
- Acronym / sponsor ID
- ID_IDCV_1301
- Conditions
- Healthy
- Keywords
- cilnidipin and valsartn, pharmacokinetic drug drug interaction, oral administration, healthy male subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| C - V - C+V | Experimental | Drug: C - V - C+VC - 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 |
| V - C - C+V | Experimental | Drug: V - C - C+VC - 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 |
| V - C+V - C | Experimental | Drug: V - C+V - CC - 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 |
| C+V - V - C | Experimental | Drug: C+V - C - VC - 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 |
| C+V - C - V | Experimental | Drug: C+V - V - CC - 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 |
| C - C+V - V | Experimental | Drug: C - C+V - VC - 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers, age 20 to 40 years
- 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
- Subjects who have no congenital or chronic disease and no abnormal symptom or opinion
- Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening
- 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
Key exclusion criteria (13 listed)
- 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
- 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 history of drug allergies (aspirin, antibiotics, including study drug etc.), or history of clinically significant allergies
- 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.
- Presence or history of drug abuse or positive result in urine drug screening test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C - V - C+VDrug will be administered to according to C - V - C+V sequence for 3 period. | Drug | C - V - C+V |
| C - C+V - VDrug will be administered to according to C - C+V - V sequence for 3 period. | Drug | C - C+V - V |
| V - C - C+VDrug will be administered to according to V - C - C+V sequence for 3 period. | Drug | V - C - C+V |
| V - C+V - CDrug will be administered to according to V - C+V - C sequence for 3 period. | Drug | V - C+V - C |
| C+V - C - VDrug will be administered to according to C+V - C - V sequence for 3 period. | Drug | C+V - V - C |
| C+V - V - CDrug will be administered to according to C+V - V - C sequence for 3 period. | Drug | C+V - C - V |
Primary outcome
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
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
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
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyoung Sang You, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C - V - C+V, C - C+V - V and V - C - C+V in people with Healthy, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.