Hypertension With DyslipidemiaPhase 1NCT03247140
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers
A Phase 1 study testing JLP-1401 and Telmisartan/Amlodipine, Rosuvastatin in people with Hypertension With Dyslipidemia, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension With Dyslipidemia
- What is being tested?
- JLP-1401 and Telmisartan/Amlodipine, Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jun 2017to 27 Nov 2017
- 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 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- Subject who has the ability and willingness to participate the whole period of trial
Who cannot join
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- Subjects who are allergic to investigational drug.
- Subjects who have a medical history which can affect the clinical trial.
- Systolic BP > 140mmHG or Diastolic BP > 90mmHg)
- AST or ALT > X 2 UNL
- History of drug abuse or positive drug screening.
- Participation in other drug studies within 3 months prior to the drug administration.
- Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Coadministration of Rosuvastatin and Telmisartan/Amlodipine in Healthy Adult Volunteers
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers
- Conditions
- Hypertension With Dyslipidemia
- Being tested
- JLP-1401, Telmisartan/Amlodipine, Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JLP-1401Drug
Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)
Telmisartan/Amlodipine, RosuvastatinDrug
Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)
| Study group | Role | What they receive |
|---|---|---|
| Group I (JLP-1401) | Experimental | JLP-1401(Telmisartan 80 mg, amlodipine 10 mg, rosuvastatin 20 mg) Receives: Drug: JLP-1401; Drug: Telmisartan/Amlodipine, Rosuvastatin |
| Group II(Telmisartan/Amlodipine, Rosuvastatin) | Experimental | Twinsta(Telmisartan 40 mg, amlodipine 5 mg) 2 tab and Crestor(rosuvastatin 20 mg) Receives: Drug: JLP-1401; Drug: Telmisartan/Amlodipine, Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Measured: 72hr after baseline
Cmax
Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Measured: 72 after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start10 Jun 2017
- Primary completion7 Aug 2017
- Study completion27 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension With DyslipidemiaStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Gul Kim, MD., Ph.D, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247140
- Sponsor's protocol ID
- JLP-1401-101-PK
- Status last verified
- Dec 2017
- First submitted
- 28 Jul 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Coadministration of Rosuvastatin and Telmisartan/Amlodipine in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03247140
- Acronym / sponsor ID
- JLP-1401-101-PK
- Conditions
- Hypertension With Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 11 Aug 2017 (actual)
- 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 PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (JLP-1401) | Experimental | Drug: JLP-1401, Drug: Telmisartan/Amlodipine, RosuvastatinJLP-1401(Telmisartan 80 mg, amlodipine 10 mg, rosuvastatin 20 mg) |
| Group II(Telmisartan/Amlodipine, Rosuvastatin) | Experimental | Drug: JLP-1401, Drug: Telmisartan/Amlodipine, RosuvastatinTwinsta(Telmisartan 40 mg, amlodipine 5 mg) 2 tab and Crestor(rosuvastatin 20 mg) |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- Subject who has the ability and willingness to participate the whole period of trial
Key exclusion criteria (8 listed)
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- Subjects who are allergic to investigational drug.
- Subjects who have a medical history which can affect the clinical trial.
- Systolic BP > 140mmHG or Diastolic BP > 90mmHg)
- AST or ALT > X 2 UNL
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 |
|---|---|---|
| JLP-1401Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin) | Drug | Group I (JLP-1401), Group II(Telmisartan/Amlodipine, Rosuvastatin) |
| Telmisartan/Amlodipine, RosuvastatinAdministration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®) | Drug | Group I (JLP-1401), Group II(Telmisartan/Amlodipine, Rosuvastatin) |
Primary outcome
AUC
Time frame: 72hr after baseline
Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Cmax
Time frame: 72 after baseline
Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
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 26 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Hypertension With Dyslipidemia
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
A Novel Digital Tool Clinicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
Hypertension, Dyslipidemia
Recruiting
Evaluation of a New Virtual Care Pathway for Older Adults With Noncommunicable Diseases
Hypertension (HTN), Diabetes
Active, not recruiting
Dietary Strategies for Remission of Type 2 Diabetes
Diabetes Mellitus, Type 2, Overweight and Obesity
RecruitingPhase 1
A Study of STX-1150 in Participants With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
Elevated LDL-C and High Cholesterol
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.
Min Gul Kim, MD., Ph.D principal investigator
Chonbuk 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 JLP-1401 and Telmisartan/Amlodipine, Rosuvastatin in people with Hypertension With Dyslipidemia, run by Jeil 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 3 inclusion and 8 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 26 Dec 2017. 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?
AUC (time frame: 72hr after baseline). The study lists 2 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 26 Dec 2017.