NCT01692717

Brief 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 \& Dohme) by comparing the serum concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

February 28, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2013

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

September 21, 2012

Last Update Submit

October 27, 2022

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    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.

Study Arms (3)

Atorvastatin

ACTIVE COMPARATOR

Citalor (Atorvastatin) - Pfizer

Drug: AtorvastatinDrug: Hydrochlorothiazide + LosartanDrug: Hydrochlorothiazide + Losartan + Atorvastatin

Hydrochlorothiazide + Losartan

ACTIVE COMPARATOR

Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp \& Dohme

Drug: AtorvastatinDrug: Hydrochlorothiazide + LosartanDrug: Hydrochlorothiazide + Losartan + Atorvastatin

Atorvastatin + Hydrochlorothiazide + Losartan

EXPERIMENTAL

Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas

Drug: AtorvastatinDrug: Hydrochlorothiazide + LosartanDrug: Hydrochlorothiazide + Losartan + Atorvastatin

Interventions

AtorvastatinDRUG

10 mg

Also known as: Citalor
AtorvastatinAtorvastatin + Hydrochlorothiazide + LosartanHydrochlorothiazide + Losartan
Hydrochlorothiazide + LosartanDRUG

12.5 mg + 50 mg

Also known as: Hyzaar
AtorvastatinAtorvastatin + Hydrochlorothiazide + LosartanHydrochlorothiazide + Losartan
Hydrochlorothiazide + Losartan + AtorvastatinDRUG

12.5 mg + 50 mg + 10 mg

Also known as: Polipílula
AtorvastatinAtorvastatin + Hydrochlorothiazide + LosartanHydrochlorothiazide + Losartan

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Location

MeSH Terms

Interventions

Atorvastatinhydrochlorothiazide, losartan drug combinationHydrochlorothiazideLosartan

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsImidazolesTetrazoles

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

September 25, 2012

Study Start

February 28, 2013

Primary Completion

May 31, 2013

Study Completion

May 31, 2013

Last Updated

October 31, 2022

Record last verified: 2022-10

Locations

BR(1)