HypertensionPhase 1NCT03609294
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy Volunteers
A Phase 1 study testing Treatment A (Fimasartan, Linagliptin) and Treatment B (Fimasartan/Linagliptin) in people with Hypertension and Diabetes, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin. 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, Diabetes
- What is being tested?
- Treatment A (Fimasartan, Linagliptin) and Treatment B (Fimasartan/Linagliptin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jul 2018to 30 Jun 2019
- 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
Who may be able to join
- Male 19-50 years of age.
- Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
- Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
- Medically healthy with no clinically significant medical history.
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening.
- Plasma donation within a month prior to the first dose of study drug.
- Participation in another clinical trial within 3 months prior to the first dose of study drug(s).
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Dahak-ro, 03080
About this study
Official title: A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg and Co-administration of Fimasartan 120 mg and Linagliptin 5 mg in Healthy Male Volunteers
The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.
Read the detailed description
This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Linagliptin and co-administration of Fimasartan and Linagliptin.
- Conditions
- Hypertension, Diabetes
- Being tested
- Treatment A (Fimasartan, Linagliptin), Treatment B (Fimasartan/Linagliptin)
- Keywords
- Fimasartan, Linagliptin
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A (Fimasartan, Linagliptin)Drug
Co-administration of Fimasartan and Linagliptin
Treatment B (Fimasartan/Linagliptin)Drug
Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B)
There will be a washout of 35 days between the each period. Receives: Drug: Treatment A (Fimasartan, Linagliptin); Drug: Treatment B (Fimasartan/Linagliptin) |
| Sequence B | Experimental | Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A)
There will be a washout of 35 days between the each period. Receives: Drug: Treatment A (Fimasartan, Linagliptin); Drug: Treatment B (Fimasartan/Linagliptin) |
| Sequency C | Experimental | Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A)
There will be a washout of 35 days between the each period. Receives: Drug: Treatment A (Fimasartan, Linagliptin); Drug: Treatment B (Fimasartan/Linagliptin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration of drug in plasma of Fimasartan, Linagliptin
Measured: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
AUClast
Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin
Measured: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start18 Jul 2018
- Primary completion4 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609294
- Sponsor's protocol ID
- BR-FLC-CT-102
- Status last verified
- Feb 2020
- First submitted
- 25 Jul 2018
- Last updated
- 5 Feb 2020
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg and Co-administration of Fimasartan 120 mg and Linagliptin 5 mg in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03609294
- Acronym / sponsor ID
- BR-FLC-CT-102
- Conditions
- Hypertension, Diabetes
- Keywords
- Fimasartan, Linagliptin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 1 Aug 2018 (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 the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.
Detailed description
This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Linagliptin and co-administration of Fimasartan and Linagliptin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Treatment A (Fimasartan, Linagliptin), Drug: Treatment B (Fimasartan/Linagliptin)Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period. |
| Sequence B | Experimental | Drug: Treatment A (Fimasartan, Linagliptin), Drug: Treatment B (Fimasartan/Linagliptin)Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period. |
| Sequency C | Experimental | Drug: Treatment A (Fimasartan, Linagliptin), Drug: Treatment B (Fimasartan/Linagliptin)Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male 19-50 years of age.
- Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
- Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
- Medically healthy with no clinically significant medical history.
Key exclusion criteria (5 listed)
- History or presence of clinically significant medical or psychiatric condition or disease.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening.
- Plasma donation within a month prior to the first dose of study drug.
- Participation in another clinical trial within 3 months prior to the first dose of study drug(s).
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 |
|---|---|---|
| Treatment A (Fimasartan, Linagliptin)Co-administration of Fimasartan and Linagliptin | Drug | Sequence A, Sequence B, Sequency C |
| Treatment B (Fimasartan/Linagliptin)Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg | Drug | Sequence A, Sequence B, Sequency C |
Primary outcome
Cmax
Time frame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
Maximum concentration of drug in plasma of Fimasartan, Linagliptin
AUClast
Time frame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin
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 5 Feb 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.
Kyung-Sang Yu, 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 Treatment A (Fimasartan, Linagliptin) and Treatment B (Fimasartan/Linagliptin) in people with Hypertension and Diabetes, 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?
The sponsor lists 4 inclusion and 5 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 5 Feb 2020. 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 (time frame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration). 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 5 Feb 2020.