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Trial record 20 of 140 for:    ZOLPIDEM

Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 1.75 mg Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02814058
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Biolab Sanus Farmaceutica

Tracking Information
First Submitted Date  ICMJE June 23, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date June 8, 2018
Actual Study Start Date  ICMJE July 5, 2017
Actual Primary Completion Date February 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
  • Area under the curve (0-last) [ Time Frame: 24 hours ]
  • Area under the curve (0-inf) [ Time Frame: 24 hours ]
  • Half life (t1/2) [ Time Frame: 24 hours ]
  • Elimination rate constant (Ke) [ Time Frame: 24 hours ]
  • Maximum serum concentration (Cmax) [ Time Frame: 24 hours ]
  • Time to reach maximum (peak) plasma concentration following drug administration (tmax) [ Time Frame: 24 hours ]
  • Volume of distribution (Vd) [ Time Frame: 24 hours ]
  • Clearance (C) [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
  • Number of adverse events [ Time Frame: 60 days ]
  • Intensity of adverse events [ Time Frame: 60 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 1.75 mg Formulation
Official Title  ICMJE Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 1.75 mg Formulation, With Fasting and Postprandial Administration, in Male and Female Healthy Volunteers, Produced by Biolab Sanus Farmacêutica Ltda
Brief Summary The purpose of this study is to evaluate the pharmacokinetics of the new formulation of zolpidem hemitartarate orodispersible tablet 1.75 mg in male and female healthy volunteers.
Detailed Description

This is a phase I study of zolpidem hemitartarate orodispersible tablet 1.75 mg in fasting and postprandial administration. Sample size is 28 healthy volunteers, male and female, aged from 18 to 50 years old.

This is an open-label, randomized, crossover study. Each volunteer will be randomized to one of the following sequencies:

Sequency 1: zolpidem hemitartarate 1.75 mg in fasting (period 1) and zolpidem hemitartarate 1.75 mg postprandial (period 2) Sequency 2: zolpidem hemitartarate 1.75 mg postprandial (period 1) and zolpidem hemitartarate 1.75 mg in fasting (period 2) Formulation will be administered in a single dose, orally in each period. Trial volunteers will be admitted in two different periods of 36 hours each, when investigational product will be administered and blood samples will be collected at pre-determined periods of time up to 24 hours for pharmacokinetics evaluation.

Primary objective is to evaluate the pharmacokinetics of the new formulation of zolpidem hemitartarate orodispersible tablet 1.75 mg in healthy volunteers. As a secondary objective, it will be evaluated if there is any pharmacokinetics difference between genders.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: zolpidem hemitartarate 1.75 mg - Sequency 1
    zolpidem hemitartarate 1.75 mg in fasting (period 1) and zolpidem hemitartarate 1.75 mg postprandial (period 2)
  • Drug: zolpidem hemitartarate 1.75 mg - Sequency 2
    zolpidem hemitartarate 1.75 mg postprandial (period 1) and zolpidem hemitartarate 1.75 mg in fasting (period 2)
Study Arms  ICMJE
  • Experimental: Sequency 1
    zolpidem hemitartarate 1.75 mg in fasting (period 1) and zolpidem hemitartarate 1.75 mg postprandial (period 2)
    Intervention: Drug: zolpidem hemitartarate 1.75 mg - Sequency 1
  • Experimental: Sequency 2
    zolpidem hemitartarate 1.75 mg postprandial (period 1) and zolpidem hemitartarate 1.75 mg in fasting (period 2)
    Intervention: Drug: zolpidem hemitartarate 1.75 mg - Sequency 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2016)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 22, 2018
Actual Primary Completion Date February 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female volunteers, aged from 18 to 50 years old (women cannot be pregnant or in breastfeeding period and should be committed to use an effective contraceptive method during the study)
  • Body mass index (BMI) greater than or equal to 18.5 and less than or equal to 29.9 kg/m2
  • Good health conditions and without significant diseases, according to best medical judgment, according to medical history, blood pressure and heart rate measurements, pulse, temperature, physical examination, electrocardiogram (ECG) and complementary laboratory tests
  • Ability to understand the nature and objectives of the trial, including risks and adverse events, willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by informed consent form signature.

Exclusion Criteria:

  • Known hypersensitivity to the investigational product (Zolpidem) or chemically related compounds
  • History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism
  • Maintenance therapy with any drugs, except oral contraceptives
  • History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic, psychiatric, cardiologic or allergic diseases of any etiology , that requires pharmacological treatment or considered as clinically relevant by the investigator
  • Electrocardiographic findings that at investigator discretion are not recommended for study participation
  • Deviations on screening laboratory results that are considered clinically relevant by the investigator
  • Smoking
  • Intake of more than five cups of coffee or tea per day
  • History of abusive use of drugs and alcohol
  • Use of regular medication two weeks prior to study enrollment or use of any medications one week prior to study enrollment
  • Hospitalization for any reason up to 8 weeks prior to start of first period of trial treatment
  • Treatment within 3 months prior to the start of trial treatment, with any drug with known and well-established toxic potential to major organs
  • Participation in any pharmacokinetics trial with more than 300 mL of blood draw or administration of any experimental drug within 12 months prior to trial treatment start
  • Donation or loss of 450 mL or more of blood within 3 months prior to trial enrollment or donation of more than 1500 mL of blood within 12 months prior to the trial treatment start
  • Positive result for the BHCG urine test, performed by female volunteers
  • Positive results for the detection of abusive drugs at urine exam
  • Result higher than 0.1 mg/L for the etilometer exam
  • Any condition, according to investigator's best judgment, that prevents the subject to participate in the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02814058
Other Study ID Numbers  ICMJE JPJ15/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biolab Sanus Farmaceutica
Study Sponsor  ICMJE Biolab Sanus Farmaceutica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: José Pedrazzoli Júnior, PhD UNIFAG - Unidade Integrada de Farmacologia e Gastroenterologia
PRS Account Biolab Sanus Farmaceutica
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP