Healthy SubjectsPhase 1NCT01692717
Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide
A Phase 1 study testing Atorvastatin, Hydrochlorothiazide + Losartan and Hydrochlorothiazide + Losartan + Atorvastatin in people with Healthy Subjects, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The objective of this clinical study, randomized, crossover is to evaluate the pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide) Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp \&… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Atorvastatin, Hydrochlorothiazide + Losartan and Hydrochlorothiazide + Losartan + Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Feb 2013to 31 May 2013
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Confirm voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
- Age between 18 and 55 years, regardless of sex, clinically healthy and present laboratory parameters within normal limits;
- BMI ≥ 18.5 and ≤ 30.
Who cannot join
- Participation in clinical trials in the 12 months preceding the survey;
- History of hypersensitivity reactions to atorvastatin, losartan hydrochlorothiazide and / or any other ingredients of medicines;
- Alterations in clinical and laboratory criteria that interfere Principal Investigator on the study results;
- Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
- Acute illness during the 07 days preceding the start of the study;
- Chronic disease that determine drug delivery, such as hypertension, diabetes or any other that requires continuous use of any medicine, including use of vitamins, mineral supplements and OTCs (over-the-counter);
Show all 11Show fewer
- Having made regular use of medication in the last 02 weeks before the onset of the study. The use of any medication that does not interfere with the physician's judgment on the pharmacokinetics of the drug under study, will not be considered as an exclusion criterion.
- Use of medications that interact with any medications association;
- History of or current use for at least 12 months of tobacco;
- Current or previous history (under 12 months) of illicit drug use;
- At the discretion of the Principal Investigator of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide Produced By Lab Hypermarcas S/A In Healthy Subjects
The objective of this clinical study, randomized, crossover is to evaluate the pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide) Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp \& Dohme) by comparing the serum concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.
Read the detailed description
The pharmacokinetic profile of the drug will also be assessed by comparing the serum concentration of active metabolites following:
- O-hydroxy atorvastatin (2-Hydroxy atorvastatin, O-HAT): metabolite of AT
- carboxylic acid (E-3174, LS-CA): active metabolite of LS
- Conditions
- Healthy Subjects
- Being tested
- Atorvastatin, Hydrochlorothiazide + Losartan, Hydrochlorothiazide + Losartan + Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Citalor
10 mg
Hydrochlorothiazide + LosartanDrug
Also called Hyzaar
12.5 mg + 50 mg
Hydrochlorothiazide + Losartan + AtorvastatinDrug
Also called Polipílula
12.5 mg + 50 mg + 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Citalor (Atorvastatin) - Pfizer Receives: Drug: Atorvastatin; Drug: Hydrochlorothiazide + Losartan; Drug: Hydrochlorothiazide + Losartan + Atorvastatin |
| Hydrochlorothiazide + Losartan | Active comparator | Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp \& Dohme Receives: Drug: Atorvastatin; Drug: Hydrochlorothiazide + Losartan; Drug: Hydrochlorothiazide + Losartan + Atorvastatin |
| Atorvastatin + Hydrochlorothiazide + Losartan | Experimental | Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas Receives: Drug: Atorvastatin; Drug: Hydrochlorothiazide + Losartan; Drug: Hydrochlorothiazide + Losartan + Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary pharmacokinetic parameters for the exercise of comparability will be unchanged dosages of analytes (AT, LS and HCTZ), assessed by AUC, Tmax, Cmax and T1 / 2.
Measured: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.
Secondary outcomes (1)
Pharmacokinetic parameters are side dosages of active metabolites O-HAT and E-3174, measured by AUC, Tmax, Cmax and T1 / 2.
Measured: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study start28 Feb 2013
- Primary completion31 May 2013
- Study completion31 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692717
- Sponsor's protocol ID
- ALHHYP0512OR-I
- Other IDs
- Version 01 May 28, 2012
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2012
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide Produced By Lab Hypermarcas S/A In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01692717
- Acronym / sponsor ID
- ALHHYP0512OR-I
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2013 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 31 May 2013 (actual)
- First posted
- 25 Sep 2012 (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 clinical study, randomized, crossover is to evaluate the pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide) Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp \& Dohme) by comparing the serum concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.
Detailed description
The pharmacokinetic profile of the drug will also be assessed by comparing the serum concentration of active metabolites following:
- O-hydroxy atorvastatin (2-Hydroxy atorvastatin, O-HAT): metabolite of AT
- carboxylic acid (E-3174, LS-CA): active metabolite of LS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatin, Drug: Hydrochlorothiazide + Losartan, Drug: Hydrochlorothiazide + Losartan + AtorvastatinCitalor (Atorvastatin) - Pfizer |
| Hydrochlorothiazide + Losartan | Active comparator | Drug: Atorvastatin, Drug: Hydrochlorothiazide + Losartan, Drug: Hydrochlorothiazide + Losartan + AtorvastatinHyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp \& Dohme |
| Atorvastatin + Hydrochlorothiazide + Losartan | Experimental | Drug: Atorvastatin, Drug: Hydrochlorothiazide + Losartan, Drug: Hydrochlorothiazide + Losartan + AtorvastatinPolipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Confirm voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
- Age between 18 and 55 years, regardless of sex, clinically healthy and present laboratory parameters within normal limits;
- BMI ≥ 18.5 and ≤ 30.
Key exclusion criteria (11 listed)
- Participation in clinical trials in the 12 months preceding the survey;
- History of hypersensitivity reactions to atorvastatin, losartan hydrochlorothiazide and / or any other ingredients of medicines;
- Alterations in clinical and laboratory criteria that interfere Principal Investigator on the study results;
- Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
- Acute illness during the 07 days preceding the start of the study;
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 |
|---|---|---|
| AtorvastatinAlso: Citalor10 mg | Drug | Atorvastatin, Atorvastatin + Hydrochlorothiazide + Losartan, Hydrochlorothiazide + Losartan |
| Hydrochlorothiazide + LosartanAlso: Hyzaar12.5 mg + 50 mg | Drug | Atorvastatin, Atorvastatin + Hydrochlorothiazide + Losartan, Hydrochlorothiazide + Losartan |
| Hydrochlorothiazide + Losartan + AtorvastatinAlso: Polipílula12.5 mg + 50 mg + 10 mg | Drug | Atorvastatin, Atorvastatin + Hydrochlorothiazide + Losartan, Hydrochlorothiazide + Losartan |
Primary outcome
The primary pharmacokinetic parameters for the exercise of comparability will be unchanged dosages of analytes (AT, LS and HCTZ), assessed by AUC, Tmax, Cmax and T1 / 2.
Time frame: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.
1 secondary outcome
Pharmacokinetic parameters are side dosages of active metabolites O-HAT and E-3174, measured by AUC, Tmax, Cmax and T1 / 2.
Time frame: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.
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 31 Oct 2022.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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 Atorvastatin, Hydrochlorothiazide + Losartan and Hydrochlorothiazide + Losartan + Atorvastatin in people with Healthy Subjects, run by Azidus Brasil at 1 site in Brazil.
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 11 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 31 Oct 2022. 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 Brazil. 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?
The primary pharmacokinetic parameters for the exercise of comparability will be unchanged dosages of analytes (AT, LS and HCTZ), assessed by AUC, Tmax, Cmax and T1 / 2. (time frame: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.). 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 31 Oct 2022.