HypertensionPhase 1NCT03250052
A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
A Phase 1 study testing (fimasartan or linagliptin) x 7days and (fimasartan and linagliptin) x 7days in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- (fimasartan or linagliptin) x 7days and (fimasartan and linagliptin) x 7days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Aug 2017to 21 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
- Inclusion Criteria (Total: 5):
- 19-50 year-old healthy male.
- 18.5kg/m2 ≤ Body mass index(BMI) ≤ 27kg/m2
- Subject who has no clinically significant medical history.
- Subject whose informed consent is obtained and who is willing to comply with protocol.
- Exclusion Criteria (Total: 19):
- Sitting systolic blood pressure(SiSBP) ≥ 140mmHg or < 115mmHg / Sitting Diastolic blood pressure(SiDBP) ≥ 90mmHg or < 70mmHg
- Upper Limits of Normal x 1.5 < Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin
- Creatinine clearance(CrCl) < 80mL/min (using Cockcroft-Gault formula)
- Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease research laboratory(VDRL)
- Participate in another clinical trial within 12 weeks prior to the first administration of Investigational product(IP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.
Read the detailed description
This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.
- Conditions
- Hypertension
- Being tested
- (fimasartan or linagliptin) x 7days, (fimasartan and linagliptin) x 7days
- Keywords
- Fimasartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(fimasartan or linagliptin) x 7daysDrug
Part A: fimasartan, Part B: linagliptin
(fimasartan and linagliptin) x 7daysDrug
Part A \& Part B: Co-administration of fimasartan and linagliptin
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days Receives: Drug: (fimasartan or linagliptin) x 7days; Drug: (fimasartan and linagliptin) x 7days |
| Part B | Experimental | Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days Receives: Drug: (fimasartan or linagliptin) x 7days; Drug: (fimasartan and linagliptin) x 7days |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Part A] AUC of fimasartan
[Part A] Area under the curve(AUC) of fimasartan in steady state
Measured: 0~24 hour after drug administration
[Part A] Cmax of fimasartan
[Part A] Cmax of fimasartan in steady state
Measured: 0~24 hour after drug administration
[Part B] AUC of Linagliptin
[Part B] Area under the curve(AUC) of Linagliptin in Steady State
Measured: 0~24 hour after drug administration
[Part B] Cmax of linagliptin
[Part B] Cmax of linagliptin in steady state
Measured: 0~24 hour after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start14 Aug 2017
- Primary completion13 Oct 2017
- Study completion21 Nov 2017
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 HypertensionStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Ran Yoon, PhD, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250052
- Sponsor's protocol ID
- BR-FLC-CT-101
- Status last verified
- Jan 2018
- First submitted
- 10 Aug 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang WY, Lee HW, Gwon MR, Cho S, Shim WS, Lee KT, Yang DH, Seong SJ, Yoon YR. A Pharmacokinetic Drug Interaction Between Fimasartan and Linagliptin in Healthy Volunteers. Drug Des Devel Ther. 2020 May 26;14:2101-2111. doi: 10.2147/DDDT.S248205. eCollection 2020.
PubMed 32546973
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03250052
- Acronym / sponsor ID
- BR-FLC-CT-101
- Conditions
- Hypertension
- Keywords
- Fimasartan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 13 Oct 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 15 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 purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.
Detailed description
This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: (fimasartan or linagliptin) x 7days, Drug: (fimasartan and linagliptin) x 7daysPeriod 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days |
| Part B | Experimental | Drug: (fimasartan or linagliptin) x 7days, Drug: (fimasartan and linagliptin) x 7daysPeriod 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| (fimasartan or linagliptin) x 7daysPart A: fimasartan, Part B: linagliptin | Drug | Part A, Part B |
| (fimasartan and linagliptin) x 7daysPart A \& Part B: Co-administration of fimasartan and linagliptin | Drug | Part A, Part B |
Primary outcome
[Part A] AUC of fimasartan
Time frame: 0~24 hour after drug administration
[Part A] Area under the curve(AUC) of fimasartan in steady state
[Part A] Cmax of fimasartan
Time frame: 0~24 hour after drug administration
[Part A] Cmax of fimasartan in steady state
[Part B] AUC of Linagliptin
Time frame: 0~24 hour after drug administration
[Part B] Area under the curve(AUC) of Linagliptin in Steady State
[Part B] Cmax of linagliptin
Time frame: 0~24 hour after drug administration
[Part B] Cmax of linagliptin in steady state
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 18 Jan 2018.
- Derived from this study: PubMed 32546973Kang WY, Lee HW, Gwon MR, Cho S, Shim WS, Lee KT, Yang DH, Seong SJ, Yoon YR. A Pharmacokinetic Drug Interaction Between Fimasartan and Linagliptin in Healthy Volunteers. Drug Des Devel Ther. 2020 May 26;14:2101-2111. doi: 10.2147/DDDT.S248205. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Young-Ran Yoon, PhD principal investigator
Kyungpook 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 (fimasartan or linagliptin) x 7days and (fimasartan and linagliptin) x 7days in people with Hypertension, run by Boryung 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?
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 18 Jan 2018. 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?
[Part A] AUC of fimasartan (time frame: 0~24 hour after drug administration). 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?
On the ClinicalTrials.gov record for NCT03250052, 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 18 Jan 2018.