HealthyPhase 1NCT05090449
Non-interaction Study of Chlorthalidone and Losartan in Fixed Combination, in Healthy Subjects, Under Fasting Conditions
A Phase 1 study testing Chlorthalidone (HIGROTON® 50), Losartan (COZZAR®) and A1+ A2 Co-administration of Chlorthalidone and Losartan in people with Healthy, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial summary
Monocentric study of no pharmacokinetic interaction between chlorthalidone and losartan, with an open, randomized, single-dose design with four periods, four sequences and crossover in healthy volunteers, under fasting conditions, administered in fixed combination (Test product of Laboratorios Silanes, SA de CV)… 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?
- Chlorthalidone (HIGROTON® 50), Losartan (COZZAR®) and A1+ A2 Co-administration of Chlorthalidone and Losartan
- 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
- 1 May 2019to 25 May 2020
- 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 participation of the subjects was voluntarily in accordance with the guidelines proposed in the General Health Law and their consent will be obtained according to the aforementioned law. Likewise, the standards set by the Declaration of Helsinki, the Brazilian Review and Good Clinical Practices will be maintained.
- Only healthy male volunteers between 18 and 55 years of age were included. - The body mass index of the subjects should be between 18.0-27.0 kg / m2 according to Quetelet.
- The 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 clinical test (12-lead electrocardiogram) carried out by a certified Clinical Laboratory and / or staff of the Center.
- The limits of variation allowed within normality in the screening visit was: blood pressure (sitting) from 90 to 129 mm Hg systolic and 60 to 79 mm Hg 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 "Measurement of Vital Signs". Vital signs will be taken after 5 minutes of resting in a sitting position.
- Subjects willing to practice abstinence as a lifestyle or use of two family planning methods (including barrier methods, non-hormonal intrauterine device or bilateral tubal obstruction, and hysterectomy) during the course of the clinical study and up to 30 days after the last dose.
- The laboratory and test examinations that will be carried out for the inclusion of the subjects during the selection visit to the study will be:
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- Complete hematic biometry with differential count: leukocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, distribution width of erythrocytes, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils.
- 27-element blood chemistry: glucose, urea, BUN, creatinine, BUN / creatinine ratio, uric acid, cholesterol, HDL cholesterol, triglyperides, LDL cholesterol, Non-HDL cholesterol, atherogenic index, total proteins, albumin, globulins, A / ratio G, total bilirubin, direct bilirubin, indirect bilirubin, ALT (alanine aminotransferase), AST (aspartate aminotransferase), alkaline phostatase, gamma-glutamyltraspeptidase, LDH, iron, calcium, sodium, potassium, and chlorine.
- General urine test. Physical examination (color, appearance, density); chemical examination (pH, leukocytes, nitrites, proteins, glucose, ketones, bilirubin, urobilinogen, hemoglobin); microscopic examination (leukocytes, erythrocytes, dysmorphic erythrocytes, casts, crystals, pavement cells, renal tubular cells, mucoid networks, bacteria, yeast).
- Hepatitis B and C serum tests: HBV surface antigen and anti-HCV Antibody.
- HIV serum tests: Anti-HIV [Human immunodeficiency virus] 1 and 2 antibodies.
- VDRL [Venereal Disease Research Laboratory] serum test.
- Urine drug abuse tests (qualitative) at screening visit and approximately 12 hours prior to each drug administration.
- Inline alcohol detection test approximately 12 hours before each drug administration.
- 12-lead electrocardiogram, which will be taken after 5 minutes of rest in the upright position.
Who cannot join
- Volunteers with a history of cardiovascular, kidney, liver, lung, muscle, metabolic, gastrointestinal, neurological, endocrine, hematopoietic, mental illness or other organic abnormalities. As well as those who have had a muscle trauma within the 21 days prior to the start of the study.
- Volunteers requiring 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. - Volunteers who have been exposed to drugs known as liver enzyme inducers or inhibitors or who have taken potentially toxic drugs within the 30 days prior to the start of the study.
- Volunteers who have received any medication, including vitamins (with or without a prescription) or herbal remedies 30 days (or 7 half-lives) prior to the start of the study. - Clinically significant abnormalities in the electrocardiographic trace. - Electrolyte disturbances: hypokalemia, hyponatremia, hypercalcemia, and symptomatic hyperuricemia.
- Volunteers who have been hospitalized for any problem during the six months prior to the start of the study.
- Subjects who received investigational drugs within 90 days (3 months) prior to the study. - Subjects allergic to study drugs: chlorthalidone and sulphonamide derivatives, as well as losartan.
- Subjects who have ingested alcohol and / or carbonated beverages and / or containing xanthines (coffee, tea, cocoa, chocolate, mate, cola soft drinks) or who have ingested charcoal-grilled food or grapefruit juice within the previous 10 hours at the beginning of each hospitalization period or subjects who smoked tobacco within 10 hours prior to the start of the study.
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- 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 drug abuse and / or alcoholism.
- Volunteers who require a special diet for any reason or are on a different diet, 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 non-cooperative attitude during the development of the study.
- Volunteers with positive urine drug abuse test or breath alcohol test.
- Volunteers who are not registered on the COFEPRIS page.
- Relationship of subordination between research subjects and researchers.
- Employees of the Sponsor and / or IFaB.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: No Pharmacokinetic Interaction Between Chlorthalidone and Losartan, in Healthy Volunteers Under Fasting Conditions, Administered in Fixed Combination Against Individual Components Administered Jointly and Separately
Monocentric study of no pharmacokinetic interaction between chlorthalidone and losartan, with an open, randomized, single-dose design with four periods, four sequences and crossover in healthy volunteers, under fasting conditions, administered in fixed combination (Test product of Laboratorios Silanes, SA de CV) against the individual components administered jointly and separately (Higroton® 50, a product of Sandoz, SA de CV and Cozaar® , a product of Schering-Plow, SA de CV)
Read the detailed description
The study was designed to recruit 36 healthy subjects, which were randomized for this study contemplating losses. All the volunteers whose data allowed at least one comparison to be made were included in the corresponding statistical analysis. The objective was to statistically compare the bioavailability of chlorthalidone (at normalized dose) and losartan potassium, in a non-interaction pharmacokinetic study after single-dose oral administration of a product with the fixed combination of active ingredients with respect to the individual components administered together and separately in healthy fasting volunteers. As a secondary objective, the tolerability of the presentations was evaluated based on the registry of adverse events at the end of the four study periods.
- Conditions
- Healthy
- Being tested
- Chlorthalidone (HIGROTON® 50), Losartan (COZZAR®), A1+ A2 Co-administration of Chlorthalidone and Losartan, Chlorthalidone + Losartan Fixed-Dose combination
- Keywords
- Chlorthalidone, Losartan, No-interaction, pharmacokinetics, Fixed-dose combination (FDC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorthalidone (HIGROTON® 50)Drug
Also called Chlo
Tablets with 50mg of Chlorthalidone, product de Sandoz, S.A. de C.V.
Losartan (COZZAR®)Drug
Also called Los
Losartan potassium 100 mg tablet, a product of Schering-Plough, S.A. C.V.
A1+ A2 Co-administration of Chlorthalidone and LosartanDrug
Also called Chlo + Los
50mg chlorthalidone + 100 mg losartan potassium
Chlorthalidone + Losartan Fixed-Dose combinationDrug
Also called FDC
Tablets with fixed combination of Chlorthalidone 25 mg and Losartan Potassium
| Study group | Role | What they receive |
|---|---|---|
| A1: Individual formulation of chlorthalidone | Active comparator | (Higroton 50, product of Sandoz, S.A. de C.V.) Receives: Drug: Chlorthalidone (HIGROTON® 50) |
| A2:Individual formulation Losartan | Active comparator | (COZAAR, product of Schering Plough, S.A. de C.V., S.A. de C.V.) Receives: Drug: Losartan (COZZAR®) |
| A3: Co-administration of individual formulations | Active comparator | Co-administration of individual formulations of chlorthalidone and losartan potassium Receives: Drug: A1+ A2 Co-administration of Chlorthalidone and Losartan |
| B: Fixed combination of chlorthalidone and losartan potassium | Experimental | B: Fixed combination of chlorthalidone and losartan potassium (product of Laboratorios Silanes S.A. de C.V.) Receives: Drug: Chlorthalidone + Losartan Fixed-Dose combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration following the treatment (Cmax)
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the maximum observed concentration following the treatment (Cmax).
Measured: Baseline, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.
The area under the curve from time zero to the last measurable concentration (AUC 0-t)
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t)using the linear trapezoidal method.
Measured: Baseline, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.
The area under the curve from time zero to infinity calculated (AUC 0-inf)
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the area under the curve from time zero to infinity calculated (AUC 0-inf).
Measured: Baseline, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.
Time of the maximum measured concentration (Tmax)
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing time of the maximum measured concentration (Tmax).
Measured: Baseline, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.
Elimination rate (Ke)
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the elimination rate (Ke), calculated by log-linear regression of the final phase of elimination.
Measured: Baseline, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.
Secondary outcomes (1)
Registry of adverse events of the presentations [Tolerability]
Determined the tolerability of the presentations based on the registry of adverse events at the end of the four study periods.
Measured: 67 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 May 2019
- Primary completion8 Apr 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Araceli G Medina Nolasco, M.D, Principal investigator, Investigación Farmacológica y Biofarmacéutica, S.A.P.I. de C.V.Liz J Medina Reyes, M.D, Principal investigator, Investigación Farmacológica y Biofarmacéutica, S.A.P.I. de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090449
- Sponsor's protocol ID
- CLRLSR-32-SIL
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bienert A, Brzeziniski R, Szalek E, Dubai V, Grzeskowiak E, Dyderski S, Drobnik L, Wolc A, Olejniczak-Rabinek M. Bioequivalence study of two losartan formulations administered orally in healthy male volunteers. Arzneimittelforschung. 2006;56(11):723-8. doi: 10.1055/s-0031-1296781.
PubMed 17220048Das AK, Dhanure S, Savalia AK, Nayak SK, Tripathy SK. Human bioequivalence evaluation of two losartan potassium tablets under fasting conditions. Indian J Pharm Sci. 2015 Mar-Apr;77(2):190-5. doi: 10.4103/0250-474x.156583.
PubMed 26009652del Castillo D, Campistol JM, Guirado L, Capdevilla L, Martinez JG, Pereira P, Bravo J, Perez R. Efficacy and safety of losartan in the treatment of hypertension in renal transplant recipients. Kidney Int Suppl. 1998 Dec;68:S135-9. doi: 10.1046/j.1523-1755.1998.06827.x.
PubMed 9839298Dudkowski C, Karim A, Munsaka M. Effects of Food Intake on the Pharmacokinetics of Azilsartan Medoxomil and Chlorthalidone Alone and in Fixed-Dose Combination in Healthy Adults. Clin Pharmacol Drug Dev. 2016 Sep;5(5):393-8. doi: 10.1002/cpdd.249. Epub 2016 Mar 4.
PubMed 27514506Mann R, Mackay F, Pearce G, Freemantle S, Wilton L. Losartan: a study of pharmacovigilance data on 14,522 patients. J Hum Hypertens. 1999 Aug;13(8):551-7. doi: 10.1038/sj.jhh.1000880.
PubMed 10455478Pentikis HS, Henderson JD, Tran NL, Ludden TM. Bioequivalence: individual and population compartmental modeling compared to the noncompartmental approach. Pharm Res. 1996 Jul;13(7):1116-21. doi: 10.1023/a:1016083429903.
PubMed 8842055Potvin D, DiLiberti CE, Hauck WW, Parr AF, Schuirmann DJ, Smith RA. Sequential design approaches for bioequivalence studies with crossover designs. Pharm Stat. 2008 Oct-Dec;7(4):245-62. doi: 10.1002/pst.294.
PubMed 17710740Shah JV, Patel DP, Shah PA, Sanyal M, Shrivastav PS. Simultaneous quantification of atenolol and chlorthalidone in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry. Biomed Chromatogr. 2016 Feb;30(2):208-16. doi: 10.1002/bmc.3537. Epub 2015 Jul 7.
PubMed 26096961Zandbergen AA, Baggen MG, Lamberts SW, Bootsma AH, de Zeeuw D, Ouwendijk RJ. Effect of losartan on microalbuminuria in normotensive patients with type 2 diabetes mellitus. A randomized clinical trial. Ann Intern Med. 2003 Jul 15;139(2):90-6. doi: 10.7326/0003-4819-139-2-200307150-00008.
PubMed 12859158
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Pharmacokinetic Interaction Between Chlorthalidone and Losartan, in Healthy Volunteers Under Fasting Conditions, Administered in Fixed Combination Against Individual Components Administered Jointly and Separately
- ClinicalTrials.gov ID
- NCT05090449
- Acronym / sponsor ID
- CLRLSR-32-SIL
- Conditions
- Healthy
- Keywords
- Chlorthalidone, Losartan, No-interaction, pharmacokinetics, Fixed-dose combination (FDC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 22 Oct 2021 (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.
Monocentric study of no pharmacokinetic interaction between chlorthalidone and losartan, with an open, randomized, single-dose design with four periods, four sequences and crossover in healthy volunteers, under fasting conditions, administered in fixed combination (Test product of Laboratorios Silanes, SA de CV) against the individual components administered jointly and separately (Higroton® 50, a product of Sandoz, SA de CV and Cozaar® , a product of Schering-Plow, SA de CV)
Detailed description
The study was designed to recruit 36 healthy subjects, which were randomized for this study contemplating losses. All the volunteers whose data allowed at least one comparison to be made were included in the corresponding statistical analysis. The objective was to statistically compare the bioavailability of chlorthalidone (at normalized dose) and losartan potassium, in a non-interaction pharmacokinetic study after single-dose oral administration of a product with the fixed combination of active ingredients with respect to the individual components administered together and separately in healthy fasting volunteers. As a secondary objective, the tolerability of the presentations was evaluated based on the registry of adverse events at the end of the four study periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1: Individual formulation of chlorthalidone | Active comparator | Drug: Chlorthalidone (HIGROTON® 50)(Higroton 50, product of Sandoz, S.A. de C.V.) |
| A2:Individual formulation Losartan | Active comparator | Drug: Losartan (COZZAR®)(COZAAR, product of Schering Plough, S.A. de C.V., S.A. de C.V.) |
| A3: Co-administration of individual formulations | Active comparator | Drug: A1+ A2 Co-administration of Chlorthalidone and LosartanCo-administration of individual formulations of chlorthalidone and losartan potassium |
| B: Fixed combination of chlorthalidone and losartan potassium | Experimental | Drug: Chlorthalidone + Losartan Fixed-Dose combinationB: Fixed combination of chlorthalidone and losartan potassium (product of Laboratorios Silanes S.A. de C.V.) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- The participation of the subjects was voluntarily in accordance with the guidelines proposed in the General Health Law and their consent will be obtained according to the aforementioned law. Likewise, the standards set by the Declaration of Helsinki, the Brazilian Review and Good Clinical Practices will be maintained.
- Only healthy male volunteers between 18 and 55 years of age were included. - The body mass index of the subjects should be between 18.0-27.0 kg / m2 according to Quetelet.
- The 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 clinical test (12-lead electrocardiogram) carried out by a certified Clinical Laboratory and / or staff of the Center.
- The limits of variation allowed within normality in the screening visit was: blood pressure (sitting) from 90 to 129 mm Hg systolic and 60 to 79 mm Hg 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 "Measurement of Vital Signs". Vital signs will be taken after 5 minutes of resting in a sitting position.
- Subjects willing to practice abstinence as a lifestyle or use of two family planning methods (including barrier methods, non-hormonal intrauterine device or bilateral tubal obstruction, and hysterectomy) during the course of the clinical study and up to 30 days after the last dose.
Key exclusion criteria (15 listed)
- Volunteers with a history of cardiovascular, kidney, liver, lung, muscle, metabolic, gastrointestinal, neurological, endocrine, hematopoietic, mental illness or other organic abnormalities. As well as those who have had a muscle trauma within the 21 days prior to the start of the study.
- Volunteers requiring 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. - Volunteers who have been exposed to drugs known as liver enzyme inducers or inhibitors or who have taken potentially toxic drugs within the 30 days prior to the start of the study.
- Volunteers who have received any medication, including vitamins (with or without a prescription) or herbal remedies 30 days (or 7 half-lives) prior to the start of the study. - Clinically significant abnormalities in the electrocardiographic trace. - Electrolyte disturbances: hypokalemia, hyponatremia, hypercalcemia, and symptomatic hyperuricemia.
- Volunteers who have been hospitalized for any problem during the six months prior to the start of the study.
- Subjects who received investigational drugs within 90 days (3 months) prior to the study. - Subjects allergic to study drugs: chlorthalidone and sulphonamide derivatives, as well as losartan.
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 |
|---|---|---|
| Chlorthalidone (HIGROTON® 50)Also: ChloTablets with 50mg of Chlorthalidone, product de Sandoz, S.A. de C.V. | Drug | A1: Individual formulation of chlorthalidone |
| Losartan (COZZAR®)Also: LosLosartan potassium 100 mg tablet, a product of Schering-Plough, S.A. C.V. | Drug | A2:Individual formulation Losartan |
| A1+ A2 Co-administration of Chlorthalidone and LosartanAlso: Chlo + Los50mg chlorthalidone + 100 mg losartan potassium | Drug | A3: Co-administration of individual formulations |
| Chlorthalidone + Losartan Fixed-Dose combinationAlso: FDCTablets with fixed combination of Chlorthalidone 25 mg and Losartan Potassium | Drug | B: Fixed combination of chlorthalidone and losartan potassium |
Primary outcome
Maximum observed concentration following the treatment (Cmax)
Time frame: Baseline, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the maximum observed concentration following the treatment (Cmax).
The area under the curve from time zero to the last measurable concentration (AUC 0-t)
Time frame: Baseline, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t)using the linear trapezoidal method.
The area under the curve from time zero to infinity calculated (AUC 0-inf)
Time frame: Baseline, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the area under the curve from time zero to infinity calculated (AUC 0-inf).
Time of the maximum measured concentration (Tmax)
Time frame: Baseline, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing time of the maximum measured concentration (Tmax).
Elimination rate (Ke)
Time frame: Baseline, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.
Evaluate the fixed dose pharmacokinetics profile of Dexketoprofen-Vitamin B, employing the elimination rate (Ke), calculated by log-linear regression of the final phase of elimination.
1 secondary outcome
Registry of adverse events of the presentations [Tolerability]
Time frame: 67 days
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 22 Oct 2021.
- Background: PubMed 17220048Bienert A, Brzeziniski R, Szalek E, Dubai V, Grzeskowiak E, Dyderski S, Drobnik L, Wolc A, Olejniczak-Rabinek M. Bioequivalence study of two losartan formulations administered orally in healthy male volunteers. Arzneimittelforschung. 2006;56(11):723-8. doi: 10.1055/s-0031-1296781.
- Background: PubMed 26009652Das AK, Dhanure S, Savalia AK, Nayak SK, Tripathy SK. Human bioequivalence evaluation of two losartan potassium tablets under fasting conditions. Indian J Pharm Sci. 2015 Mar-Apr;77(2):190-5. doi: 10.4103/0250-474x.156583.
- Background: PubMed 9839298del Castillo D, Campistol JM, Guirado L, Capdevilla L, Martinez JG, Pereira P, Bravo J, Perez R. Efficacy and safety of losartan in the treatment of hypertension in renal transplant recipients. Kidney Int Suppl. 1998 Dec;68:S135-9. doi: 10.1046/j.1523-1755.1998.06827.x.
- Background: PubMed 27514506Dudkowski C, Karim A, Munsaka M. Effects of Food Intake on the Pharmacokinetics of Azilsartan Medoxomil and Chlorthalidone Alone and in Fixed-Dose Combination in Healthy Adults. Clin Pharmacol Drug Dev. 2016 Sep;5(5):393-8. doi: 10.1002/cpdd.249. Epub 2016 Mar 4.
- Background: PubMed 10455478Mann R, Mackay F, Pearce G, Freemantle S, Wilton L. Losartan: a study of pharmacovigilance data on 14,522 patients. J Hum Hypertens. 1999 Aug;13(8):551-7. doi: 10.1038/sj.jhh.1000880.
- Background: PubMed 8842055Pentikis HS, Henderson JD, Tran NL, Ludden TM. Bioequivalence: individual and population compartmental modeling compared to the noncompartmental approach. Pharm Res. 1996 Jul;13(7):1116-21. doi: 10.1023/a:1016083429903.
- Background: PubMed 17710740Potvin D, DiLiberti CE, Hauck WW, Parr AF, Schuirmann DJ, Smith RA. Sequential design approaches for bioequivalence studies with crossover designs. Pharm Stat. 2008 Oct-Dec;7(4):245-62. doi: 10.1002/pst.294.
- Background: PubMed 26096961Shah JV, Patel DP, Shah PA, Sanyal M, Shrivastav PS. Simultaneous quantification of atenolol and chlorthalidone in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry. Biomed Chromatogr. 2016 Feb;30(2):208-16. doi: 10.1002/bmc.3537. Epub 2015 Jul 7.
- Background: PubMed 12859158Zandbergen AA, Baggen MG, Lamberts SW, Bootsma AH, de Zeeuw D, Ouwendijk RJ. Effect of losartan on microalbuminuria in normotensive patients with type 2 diabetes mellitus. A randomized clinical trial. Ann Intern Med. 2003 Jul 15;139(2):90-6. doi: 10.7326/0003-4819-139-2-200307150-00008.
- 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.
Araceli G Medina Nolasco, M.D principal investigator
Investigación Farmacológica y Biofarmacéutica, S.A.P.I. de C.V.
Liz J Medina Reyes, M.D principal investigator
Investigación Farmacológica y Biofarmacéutica, S.A.P.I. de C.V.
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 Chlorthalidone (HIGROTON® 50), Losartan (COZZAR®) and A1+ A2 Co-administration of Chlorthalidone and Losartan 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 15 inclusion and 15 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 22 Oct 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, 0.333, 0.750, 1.000, 1.250, 1.750, 2.000, 3.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000, 72.000, 96.000, 120.000 y 144.000 hours.). The study lists 5 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 NCT05090449, which also lists 9 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 22 Oct 2021.