HealthyPhase 1NCT03912285
The Pharmacokinetic Interaction Between Amlodipine and Losartan
A Phase 1 study testing Amlodipine10mg, Losartan potassium 100mg and Amlodipine plus Losartan in people with Healthy, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
This clinical trial aims to assess the pharmacokinetic interaction between amlodipine and losartan in healthy male subjects. 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?
- Amlodipine10mg, Losartan potassium 100mg and Amlodipine plus Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2008to 9 Jun 2009
- 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
- Healthy volunteers aged between ≥ 20 and ≤ 45 years old
- Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
- Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
- Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study
Who cannot join
- History or presence of a clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
- With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
- Any medical history that may affect drug absorption, distribution, metabolism, and excretion
- Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- Any clinically significant active chronic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
Seoul, 136-705
About this study
Official title: Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans
This clinical trial aims to assess the pharmacokinetic interaction between amlodipine and losartan in healthy male subjects.
- Conditions
- Healthy
- Being tested
- Amlodipine10mg, Losartan potassium 100mg, Amlodipine plus Losartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine10mgDrug
Amlodipine 10mg will be administered orally twice a day for 9 days
Losartan potassium 100mgDrug
Losartan 100mg will be administered orally once a day for 9 days
Amlodipine plus LosartanDrug
Amlodipine plus Losartan same way as "arm: amlodipine" and "arm: losartan"
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine, losartan, and amlodipine plus losartan | Experimental | Period 1:
amlodipine 10mg will be administered orally once a day for 9 days.
Period 2:
losartan 100mg will be administered orally once a day for 9 days after 13 days of the washout period.
Period 3:
amlodipine 10mg once a day plus losartan 100mg once a day will be administered orally for 9 days after 6 days of the washout period. Receives: Drug: Amlodipine10mg; Drug: Losartan potassium 100mg; Drug: Amlodipine plus Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
Measured: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Cmax,ss(Maximum plasma concentration of the drug at steady state)
Measured: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Secondary outcomes (6)
Cmin,ss(Minimum concentration of the drug in plasma at steady state)
Measured: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Tmax,ss(Time to maximum plasma concentration at steady state)
Measured: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
1/2(Terminal elimination half-life)
Measured: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
CLss/F(Apparent total body clearance of the drug from plasma at steady state)
Measured: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Vd,ss/F(Apparent volume of distribution at steady state)
Measured: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
PTF(Peak-to-trough fluctuation)
Measured: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start10 Jan 2008
- Primary completion17 Mar 2009
- Study completion9 Jun 2009
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
- Not applicable
- Intervention model
- Single group
- Model description
- an open-label, three-period, fixed-sequence clinical trial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanmi Pharmaceutical co., ltd.
- Responsible party
- Principal investigator, Ji-Young Park, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912285
- Sponsor's protocol ID
- HM-ALOS-101
- Status last verified
- Apr 2019
- First submitted
- 9 Apr 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans
- ClinicalTrials.gov ID
- NCT03912285
- Acronym / sponsor ID
- HM-ALOS-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Hanmi Pharmaceutical co., ltd.
- Study start
- 10 Jan 2008 (actual)
- Primary completion
- 17 Mar 2009 (actual)
- Study completion
- 9 Jun 2009 (actual)
- First posted
- 11 Apr 2019 (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.
This clinical trial aims to assess the pharmacokinetic interaction between amlodipine and losartan in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- an open-label, three-period, fixed-sequence clinical trial
| Arm | Type | Receives |
|---|---|---|
| Amlodipine, losartan, and amlodipine plus losartan | Experimental | Drug: Amlodipine10mg, Drug: Losartan potassium 100mg, Drug: Amlodipine plus LosartanPeriod 1: amlodipine 10mg will be administered orally once a day for 9 days. Period 2: losartan 100mg will be administered orally once a day for 9 days after 13 days of the washout period. Period 3: amlodipine 10mg once a day plus losartan 100mg once a day will be administered orally for 9 days after 6 days of the washout period. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers aged between ≥ 20 and ≤ 45 years old
- Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
- Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
- Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study
Key exclusion criteria (5 listed)
- History or presence of a clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
- With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
- Any medical history that may affect drug absorption, distribution, metabolism, and excretion
- Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- Any clinically significant active chronic disease
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 |
|---|---|---|
| Amlodipine10mgAmlodipine 10mg will be administered orally twice a day for 9 days | Drug | Amlodipine, losartan, and amlodipine plus losartan |
| Losartan potassium 100mgLosartan 100mg will be administered orally once a day for 9 days | Drug | Amlodipine, losartan, and amlodipine plus losartan |
| Amlodipine plus LosartanAmlodipine plus Losartan same way as "arm: amlodipine" and "arm: losartan" | Drug | Amlodipine, losartan, and amlodipine plus losartan |
Primary outcome
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Cmax,ss(Maximum plasma concentration of the drug at steady state)
Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
6 secondary outcomes
Cmin,ss(Minimum concentration of the drug in plasma at steady state)
Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Tmax,ss(Time to maximum plasma concentration at steady state)
Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
1/2(Terminal elimination half-life)
Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
CLss/F(Apparent total body clearance of the drug from plasma at steady state)
Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Vd,ss/F(Apparent volume of distribution at steady state)
Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
PTF(Peak-to-trough fluctuation)
Time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
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 12 Apr 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Amlodipine10mg, Losartan potassium 100mg and Amlodipine plus Losartan in people with Healthy, run by Korea University Anam Hospital 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 12 Apr 2019. 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?
AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state) (time frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46). 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 12 Apr 2019.