HypertensionPhase 1NCT01806324
A Study to Evaluate Pharmacokinetics and Potential Drug Interactions of a Fixed-dose Combination Tablet, HL-040XC, in Healthy Male Subjects
A Phase 1 study testing HL040XC and Losartan + Atorvastatin in people with Hypertension and Hyperlipidemia, run by HanAll BioPharma Co., Ltd. at 1 site in United States.
Trial summary
The objective of this study is: To evaluate the pharmacokinetics and safety of an experimental combination tablet containing 20 mg atorvastatin and 50 mg losartan potassium when administered orally as a single dose to healthy male subjects, compared with the concomitant administration of 20 mg atorvastatin and 50 mg… 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, Hyperlipidemia
- What is being tested?
- HL040XC and Losartan + Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 19 and 50 years of age, inclusive.
- Subjects who weigh at least 121 pounds (55 kg), and are within ± 20% of their of ideal body weight (IBW). IBW (kg) = [height (cm) - 100] x 0.9.
- Subjects who don't have any congenital or chronic disease.
- Subjects who don't have any clinically significant abnormality on vital sign measurement, physical examination, clinical lab test, and ECG test at Screening.
- Subjects who are able to read and understand the consent form.
Who cannot join
- Subjects who have any history or presence of hypersensitivity to HMG-CoA reductase inhibitors such as atorvastatin or angiotensin receptor blockers such as losartan.
- Subjects who have any medical history that may affect the absorption, distribution, metabolism, and excretion of study drugs (e.g., cardiovascular, respiratory, renal, endocrinal, hematological, digestive, neurological, or psychiatric disease).
- Subjects who have a creatinine clearance < 80 mL/min, which is calculated by Cockcroft-Gault equation: (140 - age) x (Wt in kg) / (72 x sCr).
- Subjects who had a severe injury or surgery within 4 weeks prior to Screening.
- Subjects who have a positive drug screen.
- Subjects who take any prescription or herbal drug within 1 week prior to Screening.
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- Subjects who take any over-the counter (OTC) drug, which may affect this study or the subject's safety according to the judgment of investigator, at Screening.
- Subjects who take any herbal drug containing St. John's Wort or other drugs, which are metabolized by CYP3A4 enzyme or inhibit or stimulate CYP enzyme (e.g., itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitor, nefazodone) within 4 weeks prior to Screening.
- Subjects who have abnormal meal pattern that may affect the absorption, distribution, metabolism, and excretion of study drugs (e.g., taking grapefruit juice over 1 L per day).
- Subjects who received an investigational product within 4 weeks prior to Screening.
- Subjects who have donated blood within 6 weeks prior to Screening.
- Subjects who consume alcohol over 21 units per week (1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol) and can't accept the prohibition of alcohol during this clinical study.
- Subjects who smoke more than 10 cigarettes per day.
- Subjects who have low blood pressure (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or high blood pressure (systolic ≥ 150 mmHg or diastolic ≥ 95 mmHg) at Screening.
- Subjects who test positive on serology HBsAg, HCV Ab, HIV Ab or VDRL at Screening.
- Subjects who have active liver disease or elevated serum transaminase level higher than 3 times of upper limit of normal.
- Subjects who have the inability in the opinion of the investigator to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is:
To evaluate the pharmacokinetics and safety of an experimental combination tablet containing 20 mg atorvastatin and 50 mg losartan potassium when administered orally as a single dose to healthy male subjects, compared with the concomitant administration of 20 mg atorvastatin and 50 mg losartan potassium tablets.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- HL040XC, Losartan + Atorvastatin
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL040XCDrug
single dose
Losartan + AtorvastatinDrug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| HL040XC(Atorvastatin+Losartan) | Experimental | HL040XC lag time released combination drug Receives: Drug: HL040XC |
| Losartan + Atorvastatin | Active comparator | Coadministration group Receives: Drug: Losartan + Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
To evaluate its bioequivalency in Cmax and AUC of each test group
Measured: 0 ~ 48hr
AUC
To evaluate bioequvalency of each group
Measured: 0~48HR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionDec 2012
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806324
- Sponsor's protocol ID
- HL-040XC-US-001
- Status last verified
- Mar 2013
- First submitted
- 18 Apr 2012
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Pharmacokinetics and Potential Drug Interactions of a Fixed-dose Combination Tablet, HL-040XC, in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01806324
- Acronym / sponsor ID
- HL-040XC-US-001
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Mar 2013 (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 objective of this study is:
To evaluate the pharmacokinetics and safety of an experimental combination tablet containing 20 mg atorvastatin and 50 mg losartan potassium when administered orally as a single dose to healthy male subjects, compared with the concomitant administration of 20 mg atorvastatin and 50 mg losartan potassium tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HL040XC(Atorvastatin+Losartan) | Experimental | Drug: HL040XCHL040XC lag time released combination drug |
| Losartan + Atorvastatin | Active comparator | Drug: Losartan + AtorvastatinCoadministration group |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects between 19 and 50 years of age, inclusive.
- Subjects who weigh at least 121 pounds (55 kg), and are within ± 20% of their of ideal body weight (IBW). IBW (kg) = [height (cm) - 100] x 0.9.
- Subjects who don't have any congenital or chronic disease.
- Subjects who don't have any clinically significant abnormality on vital sign measurement, physical examination, clinical lab test, and ECG test at Screening.
- Subjects who are able to read and understand the consent form.
Key exclusion criteria (17 listed)
- Subjects who have any history or presence of hypersensitivity to HMG-CoA reductase inhibitors such as atorvastatin or angiotensin receptor blockers such as losartan.
- Subjects who have any medical history that may affect the absorption, distribution, metabolism, and excretion of study drugs (e.g., cardiovascular, respiratory, renal, endocrinal, hematological, digestive, neurological, or psychiatric disease).
- Subjects who have a creatinine clearance < 80 mL/min, which is calculated by Cockcroft-Gault equation: (140 - age) x (Wt in kg) / (72 x sCr).
- Subjects who had a severe injury or surgery within 4 weeks prior to Screening.
- Subjects who have a positive drug screen.
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 |
|---|---|---|
| HL040XCsingle dose | Drug | HL040XC(Atorvastatin+Losartan) |
| Losartan + AtorvastatinSingle dose | Drug | Losartan + Atorvastatin |
Primary outcome
Cmax
Time frame: 0 ~ 48hr
To evaluate its bioequivalency in Cmax and AUC of each test group
AUC
Time frame: 0~48HR
To evaluate bioequvalency of each group
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 7 Mar 2013.
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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 HL040XC and Losartan + Atorvastatin in people with Hypertension and Hyperlipidemia, run by HanAll BioPharma Co., Ltd. at 1 site in United States.
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 5 inclusion and 17 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 7 Mar 2013. 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 United States. 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: 0 ~ 48hr). 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 7 Mar 2013.