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AzTrials

HealthyPhase 1NCT04895059

Study of no Pharmacokinetic Interaction Between Rosuvastatin 20mg and Ezetimibe10mg, Fixed Dose vs Individual Components

A Phase 1 study testing Rosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose, Rosuvastatin 20mg and Ezetimibe 10mg in people with Healthy, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Monocentric study of no pharmacokinetic interaction between rosuvastatin 20 mg and ezetimibe 10 mg. An open design, randomized, single dose with three periods, six sequences and crossed, in healthy volunteers with fasting conditions, managed in fixed dose combination (Sponsor Laboratorios Silanes S.A. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Rosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose, Rosuvastatin 20mg and Ezetimibe 10mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteMexico
Study dates
30 Apr 2017to 22 Jan 2018
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

  • The body mass index of the subjects should be between 18.0-27.0 according to Quetelet.
  • Women of childbearing age should have a family planning method (including barrier methods, non-hormonal intrauterine devices or bilateral tubal obstruction) or practice abstinence as a lifestyle during the development of the clinical study.
  • Volunteers must be healthy, a criterion determined by the results of a complete medical history carried out by the doctors of the Clinical Research site and the laboratory and cabinet studies carried out in certified Clinical Laboratories.
  • The limits of variation allowed within normality in the selection visit will be: blood pressure (sitting) from 90 to 130 mmHg systolic and 60 to 90 mmHg diastolic, heart rate between 50 and 100 beats per minute and respiratory rate between 14 and 20 breaths per minute according to current SOP with code CLI-DES-008 " Measure vital sign".
  • The vital signs will be taken after 5 minutes of rest in the sedent position.
  • The laboratory and office tests that were carried out for the inclusion of the subjects to the study will be: 1. Complete hematic biometry with differential count: Leukocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean concentration of corpuscular hemoglobin, distribution width of erythrocytes, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils. 2.27-element blood chemistry: glucose, urea, BUN, creatinine, BUN / creatinine ratio, uric acid, cholesterol, HDL cholesterol, triglycerides, LDL cholesterol, non-HDL cholesterol, atherogenic index, total proteins, albumin, globulins, A / ratio G, total bilirubin, direct bilirubin, indirect bilirubin, TGO, TGP, total alkaline phostatase, gamma-glutamyltranspeptidase, DHL, iron, calcium sodium, potassium and chlorine. 3.General urine test. Physical examination (color, appearance, density); chemical test (pH, leukocytes, nitrites, proteins, glucose, ketones, bilirubin, urobilinogen, hemoglobin); microscopic examination (leukocytes, erythrocytes, dysformic erythrocytes, casts, crystals, pavement cells, renal tubular cells, mucoid networks, bacteria and yeasts. 4. Hepatitis B and C test: HBV surface antigen and anti-HCV antibody. 5. HIV test: Anti-HIV 1 and 2 antibodies. 6. VDRL test. 7. Urine drug abuse test at screening visit and approximately 12 hours prior to drug administration. 8. Online alcohol detection test approximately 12 hours prior to drug admission. 9. Serum pregnancy test at screening visit and urine pregnancy test (qualitative) approximately 12 hours before drug administration. 10. 12-lead electrocardiogram (valid for no more than 3 months).

Who cannot join

  • Volunteers with a history of cardiovascular, neurological (uncontrolled seizures), kidney (severe kidney failure), liver (liver failure, active liver disease or increased transaminases that exceed three times the upper limit of normal), pulmonary, muscular (myopathies) ), rhabdomyolysis, hereditary muscle disorders), metabolic, gastrointestinal including constipation, neurological, endpocrine (diabetes mellitus, hypothyroidism), hematopoietic or any type of anemia, mental illness or other organic abnormalities. As well as those who have had a muscle trauma within the 21 days prior to the study.
  • Volunteers who require any medication during the course of the study other than the medication being studied.
  • Volunteers with a history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer.
  • History of hereditary galactose intolerance, Lapp lactase deficiency, or glucose or galactose malabsorption.
  • Volunteers who have been exposed to medications known as liver enzyme inducers or inhibitors or who have taken potentially toxic medications within 30 days prior to the start of the study.
  • Volunteers who have received any medications, including vitamins (with or without a prescription) or herbal remedies 30 days (or 7 half-lives) prior to the start of the study.
Show all 16Show fewer
  • Current or recent use of fibrates, niacin, cyclosporine, and protease inhibitors.
  • History of muscle toxicity with another HMG-CoA inhibitor or fibrates.
  • Volunteers who have been hospitalized for any problem during the six months prior to the start of the study.
  • Subjects allergic to any medicine, food or substance. Subjects who have ingested alcohol and / or carbonated and / or xanthine-containing beverages (coffee, tea, cocoa, chocolate, mate, cola soft drinks) or who have ingested charcoal-grilled food or grapefruit juice within 10 hours prior to the start of the hospitalization period, or subjects who smoked tobacco within 10 hours prior to the start of the study.
  • Subjects who have donated or lost 450 ml or more of blood within the 60 days prior to the start of the study.
  • Subjects with a history of abuse and dependence on alcohol or psychoactive substances.
  • Volunteers requiring a special diet for any reason, for example vegetarian.
  • Incapacity of any kind that makes it impossible for the volunteer to understand the nature, objective and possible consequences of the study.
  • Evidence of uncooperative attitude during the study.
  • Volunteers with positive drug abuse, pregnancy and / or alcohol testing.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Laboratorio Silanes, S.A. de C.V.

    Mexico City, 11000

Other trials in Mexico

About this study

Official title: Study of no Pharmacokinetic Interaction Between Rosuvastatin 20 mg and Ezetimibe 10 mg, Open Design, Randomized, Single Dose, 3x6, Crossove, Healthy Volunteers in Fasting, in Fixed Combination Against Individuals Components Managed

Monocentric study of no pharmacokinetic interaction between rosuvastatin 20 mg and ezetimibe 10 mg. An open design, randomized, single dose with three periods, six sequences and crossed, in healthy volunteers with fasting conditions, managed in fixed dose combination (Sponsor Laboratorios Silanes S.A. de C.V.) versus individual components managed by separated (Crestor®, product of Astrazeneca, S.A. de C.V and Ezetrol®. product of Undra S.A. de C.V.)

Read the detailed description

To statistically compare the bioavailability of rosuvastatin 20 mg and ezetimibe 10 mg in a pharmacokinetic non-interference study, after single-dose oral administration of a product with the fixed combination of active ingredients with respect to the individual components administered separately in healthy volunteers fasting. In the same way, the safety of the presentations will be evaluated based on the registry of adverse events at the end of the three study periods. The classic 90% confidence intervals will be determined for the intra-individual ratios (test / reference) of the main parameters AUC0-t, AUC0-inf, Cmax for rosuvastatin and ezetimibe.

Conditions
Healthy
Being tested
Rosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose, Rosuvastatin 20mg, Ezetimibe 10mg
Keywords
Dyslipidemia, Rosuvastatin, Ezetimibe, Cholesterol
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rosuvastatin (20mg) /Ezetimibe (10mg) in fixed doseDrug

    Also called ROSU/EZET

    Form: Tablets Dosage: 20 mg Adminstration way: Oral

  • Rosuvastatin 20mgDrug

    Also called ROSU (Crestor®)

    Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration way: Oral

  • Ezetimibe 10mgDrug

    Also called EZET (Ezetrol®)

    Pharmaceutical Form: Tablets Dosage: 10 mg Adminstration way: Oral

Study groups in NCT04895059
Study groupRoleWhat they receive
Group A: Rosuvastatin / Ezetimibe fixed doseExperimentalIn fixed dose Pharmaceutical Form: Tablets Dosage: 20 mg / 10 mg Administration way: oral
Receives: Drug: Rosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose
Group B: Rosuvastatin (Crestor®)Active comparatorPharmaceutical Form: Tablets Dosage: 20 mg Adminstration wat: Oral
Receives: Drug: Rosuvastatin 20mg
Group C: Ezetimibe (Ezetrol®)Active comparatorPharmaceutical Form: Tablets Dosage: 10 mg Adminstration wat: Oral
Receives: Drug: Ezetimibe 10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed concentration following the treatment (Cmax

    Evaluate the fixed dose pharmacokinetics profile of rosuvastatin/ezetimibe, employing the maximum observed concentration following the treatment (Cmax)

    Measured: Baseline, 0.25, 0.50, 0.75, 1.00. 2.00, 3.00, 4.00, 5.00, 6.00. 7.00, 8.00, 10.00, 14.00, 24.00. 36.00, 48.00. 72.00 and 96.00 hours

  2. The area under the curve from time zero to the last measurable concentration (AUC 0-t)using the linear trapezoidal linear-interpolation method

    Evaluate the fixed dose pharmacokinetics profile of rosuvastatin/ezetimibe, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t)using the linear trapezoidal linear-interpolation method.

    Measured: Baseline, 0.25, 0.50, 0.75, 1.00. 2.00, 3.00, 4.00, 5.00, 6.00. 7.00, 8.00, 10.00, 14.00, 24.00. 36.00, 48.00. 72.00 and 96.00 hours

  3. The area under the curve from time zero to infinity calculated (AUC 0-inf),

    Evaluate the fixed dose pharmacokinetics profile of rosuvastatin/ezetimibe, employing the area under the curve from time zero to infinity calculated (AUC 0-inf).

    Measured: Baseline, 0.25, 0.50, 0.75, 1.00. 2.00, 3.00, 4.00, 5.00, 6.00. 7.00, 8.00, 10.00, 14.00, 24.00. 36.00, 48.00. 72.00 and 96.00 hours

  4. Time of the maximum measured concentration (Tmax).

    Evaluate the fixed dose pharmacokinetics profile of Rosuvastatin/ezetimibe, employing time of the maximum measured concentration (Tmax).

    Measured: Baseline, 0.25, 0.50, 0.75, 1.00. 2.00, 3.00, 4.00, 5.00, 6.00. 7.00, 8.00, 10.00, 14.00, 24.00. 36.00, 48.00. 72.00 and 96.00 hours

Secondary outcomes (5)

  1. Sitting blood pressure (mmHg).

    The sitting blood pressure was measured and registered at case format report throughout the study.

    Measured: Prior to dosing, at 02.00, 06.00,14.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours

  2. Pulse rate (p/m).

    The pulse rate was measured and registered at case format report throughout the study.

    Measured: Prior to dosing, at 02.00, 06.00,14.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours

  3. Respiratory rate (rr).

    The respiratory rate was measured and registered at case format report throughout the study.

    Measured: Prior to dosing, at 02.00, 06.00,14.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours

  4. Axillary-body temperature (°C).

    The axillary-body temperature was measured and registered at case format report throughout the study.

    Measured: Prior to dosing, at 02.00, 06.00,14.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours

  5. Adverse events

    Any adverse event were classified by severity, treatment and its relationship with the study drug was evaluated.

    Measured: 96 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start30 Apr 2017
  3. Primary completion15 Jan 2018
  4. Study completion22 Jan 2018

Resources

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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895059
Sponsor's protocol ID
RSEZ-25-SIL
Status last verified
Aug 2021
First submitted
17 May 2021
Last updated
24 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chu NN, Chen WL, Xu HR, Li XN. Pharmacokinetics and safety of ezetimibe/simvastatin combination tablet: an open-label, single-dose study in healthy Chinese subjects. Clin Drug Investig. 2012 Dec;32(12):791-8. doi: 10.1007/s40261-012-0013-5.

    PubMed 23109219

  • Fellstrom BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Gronhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Suleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wuthrich RP, Gottlow M, Johnsson E, Zannad F; AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407. doi: 10.1056/NEJMoa0810177. Epub 2009 Mar 30.

    PubMed 19332456

  • Glynn RJ, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Ridker PM. A randomized trial of rosuvastatin in the prevention of venous thromboembolism. N Engl J Med. 2009 Apr 30;360(18):1851-61. doi: 10.1056/NEJMoa0900241. Epub 2009 Mar 29.

    PubMed 19329822

  • Kanazawa I, Yamaguchi T, Yamauchi M, Sugimoto T. Rosuvastatin increased serum osteocalcin levels independent of its serum cholesterol-lowering effect in patients with type 2 diabetes and hypercholesterolemia. Intern Med. 2009;48(21):1869-73. doi: 10.2169/internalmedicine.48.2645. Epub 2009 Nov 2.

    PubMed 19881236

  • Kim KJ, Kim SH, Yoon YW, Rha SW, Hong SJ, Kwak CH, Kim W, Nam CW, Rhee MY, Park TH, Hong TJ, Park S, Ahn Y, Lee N, Jeon HK, Jeon DW, Han KR, Moon KW, Chae IH, Kim HS. Effect of fixed-dose combinations of ezetimibe plus rosuvastatin in patients with primary hypercholesterolemia: MRS-ROZE (Multicenter Randomized Study of ROsuvastatin and eZEtimibe). Cardiovasc Ther. 2016 Oct;34(5):371-82. doi: 10.1111/1755-5922.12213.

    PubMed 27506635

  • Lorgelly PK, Briggs AH, Wedel H, Dunselman P, Hjalmarson A, Kjekshus J, Waagstein F, Wikstrand J, Janosi A, van Veldhuisen DJ, Barrios V, Fonseca C, McMurray JJ; CORONA Study Group. An economic evaluation of rosuvastatin treatment in systolic heart failure: evidence from the CORONA trial. Eur J Heart Fail. 2010 Jan;12(1):66-74. doi: 10.1093/eurjhf/hfp172.

    PubMed 20023047

  • McKenney JM. Efficacy and safety of rosuvastatin in treatment of dyslipidemia. Am J Health Syst Pharm. 2005 May 15;62(10):1033-47. doi: 10.1093/ajhp/62.10.1033.

    PubMed 15901588

  • Nakano T, Inoue I, Takenaka Y, Ono H, Katayama S, Awata T, Murakoshi T. Ezetimibe Promotes Brush Border Membrane-to-Lumen Cholesterol Efflux in the Small Intestine. PLoS One. 2016 Mar 29;11(3):e0152207. doi: 10.1371/journal.pone.0152207. eCollection 2016.

    PubMed 27023132

  • Leiter LA, Betteridge DJ, Farnier M, Guyton JR, Lin J, Shah A, Johnson-Levonas AO, Brudi P. Lipid-altering efficacy and safety profile of combination therapy with ezetimibe/statin vs. statin monotherapy in patients with and without diabetes: an analysis of pooled data from 27 clinical trials. Diabetes Obes Metab. 2011 Jul;13(7):615-28. doi: 10.1111/j.1463-1326.2011.01383.x.

    PubMed 21332628

  • Takayama T, Hiro T, Yamagishi M, Daida H, Hirayama A, Saito S, Yamaguchi T, Matsuzaki M; COSMOS Investigators. Effect of rosuvastatin on coronary atheroma in stable coronary artery disease: multicenter coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Circ J. 2009 Nov;73(11):2110-7. doi: 10.1253/circj.cj-09-0358. Epub 2009 Oct 5.

    PubMed 19801853

  • Yu CC, Lai WT, Shih KC, Lin TH, Lu CH, Lai HJ, Hanson ME, Hwang JJ. Efficacy, safety and tolerability of ongoing statin plus ezetimibe versus doubling the ongoing statin dose in hypercholesterolemic Taiwanese patients: an open-label, randomized clinical trial. BMC Res Notes. 2012 May 23;5:251. doi: 10.1186/1756-0500-5-251.

    PubMed 22621316

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose, Rosuvastatin 20mg and Ezetimibe 10mg in people with Healthy, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

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 6 inclusion and 16 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 24 Aug 2021. 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 Mexico. 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?

Maximum observed concentration following the treatment (Cmax (time frame: Baseline, 0.25, 0.50, 0.75, 1.00. 2.00, 3.00, 4.00, 5.00, 6.00. 7.00, 8.00, 10.00, 14.00, 24.00. 36.00, 48.00. 72.00 and 96.00 hours). 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 NCT04895059, which also lists 11 linked publications.

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 24 Aug 2021.

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