HealthyPhase 1NCT01735890
Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet
A Phase 1 study testing CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg in people with Healthy, run by HK inno.N Corporation.
Trial summary
The objectives of this study are: To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Nov 2012
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Years 20-45
- 18 ≤ BMI < 27kg/m²
- volunteer
Who cannot join
- Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
- Subject with symptoms of acute disease within 28days prior to study medication dosing
- Subject with gastrointestinal diseases or surgery which might significantly change absorption of medicines
- Use of any prescription medication within 14 days prior to study medication dosing and over-the-counter medication including oriental medication within 7 days prior to study medication dosing
- Subject with known for hypersensitivity reaction to amlodipine and valsartan
- Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5 ii. Total bilirubin > Upper normal limit × 1.5 iii. eGFR< 50mL/min ⅳ. continued serum potassium concentration abnormal status (on baseline visit, < 3.5mEq/L or > 5.5mEq/L)
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- Positive test results for HBs Ab, HCV Ab, Syphilis regain test
- Drug abuse or continued excessive use of caffeine (caffeine > five cups/day), severe heavy smoker (cigarette > 10 cigarettes per day) and alcohol(alcohol>30g/day)
- Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice
- Clinically significant hypotension(SBP < 100mmHg, DBP ≤65mmHg) or hypertension(SBP 100mmHg, DBP < 65mmHg) when screening period
- Participation in any clinical investigation within 60days prior to study medication dosing
- Subjects with whole blood donation within 60days, component blood donation within 20days and blood transfusion within 30days prior to study medication dosing
- Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
About this study
Official title: A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers
The objectives of this study are:
- To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
- To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
- Conditions
- Healthy
- Being tested
- CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg
- Keywords
- Safety, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mgDrug
single dose
| Study group | Role | What they receive |
|---|---|---|
| CJ Amlodipine/Valsartan 10/160mg | Experimental | Not described Receives: Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg |
| Novartis Exforge 10/160mg | Active comparator | Not described Receives: Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic parameters of amlodipine and valsartan(Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast))
Measured: Up to 144 hours
Secondary outcomes (1)
AUCinf, Tmax, T1/2, CL/F
Measured: up to 144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735890
- Sponsor's protocol ID
- CJ_AMV_102
- Status last verified
- Nov 2012
- First submitted
- 25 Nov 2012
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Nam JH, Oh M, Kim HJ, Han SK, Kim EJ, Song GS, Kim EY, Shin JG, Ghim JL, Kim HS. Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Jan;53(1):66-74. doi: 10.5414/CP202045.
PubMed 25034618
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet After a Single Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01735890
- Acronym / sponsor ID
- CJ_AMV_102
- Conditions
- Healthy
- Keywords
- Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 Nov 2012 (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 objectives of this study are:
- To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
- To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CJ Amlodipine/Valsartan 10/160mg | Experimental | Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg |
| Novartis Exforge 10/160mg | Active comparator | Drug: CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Years 20-45
- 18 ≤ BMI < 27kg/m²
- volunteer
Key exclusion criteria (13 listed)
- Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
- Subject with symptoms of acute disease within 28days prior to study medication dosing
- Subject with gastrointestinal diseases or surgery which might significantly change absorption of medicines
- Use of any prescription medication within 14 days prior to study medication dosing and over-the-counter medication including oriental medication within 7 days prior to study medication dosing
- Subject with known for hypersensitivity reaction to amlodipine and valsartan
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 |
|---|---|---|
| CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mgsingle dose | Drug | CJ Amlodipine/Valsartan 10/160mg, Novartis Exforge 10/160mg |
Primary outcome
pharmacokinetic parameters of amlodipine and valsartan(Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast))
Time frame: Up to 144 hours
1 secondary outcome
AUCinf, Tmax, T1/2, CL/F
Time frame: up to 144 hours
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 13 Sep 2013.
- Derived from this study: PubMed 25034618Nam JH, Oh M, Kim HJ, Han SK, Kim EJ, Song GS, Kim EY, Shin JG, Ghim JL, Kim HS. Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Jan;53(1):66-74. doi: 10.5414/CP202045.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg in people with Healthy, run by HK inno.N Corporation.
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 3 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 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
pharmacokinetic parameters of amlodipine and valsartan(Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast)) (time frame: Up to 144 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01735890, which also lists 1 linked publication.
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 13 Sep 2013.