Pharmacokinetics of Zolpidem Orodispersible Tablet

January 31, 2017 updated by: Biolab Sanus Farmaceutica

Phase I Randomized Clinical Trial of Evaluation of Zolpidem Hemitartarate Pharmacokinetics (Orodispersible Tablet 1.75 mg and 3.50 mg) After Single Dose Oral Administration in Male and Female Healthy Subjects

This is a Phase I, open-label, randomized trial to evaluate the single-dose pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg). Sample size is 48 participants, male or female, aged above 18 years-old.

Primary objective is to evaluate pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg), and secondary objective is to evaluate safety and tolerability of the investigational product.

Participants will be admitted for a period of 36 hours, when investigational product will be administered, and blood samples, at pre-determined time periods, will be collected for pharmacokinetics.

Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female study participants, aged above 18 years-old; women cannot be pregnant or breastfeeding
  • Body mass index (BMI) greater than or equal to 19 and less than or equal to 28.75 Kg/m2
  • Good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, 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 of serious adverse reactions or hypersensitivity to any drug
  • History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism
  • Chronic therapy with any drugs, except oral contraceptives
  • History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure
  • Electrocardiographic findings that, at investigator criteria, are not recommended for study participation
  • Deviations on screening laboratory results that are considered as clinically relevant by the researcher
  • Smoking
  • Intake of more that 5 cups of coffee or tea per day
  • Unusual food habits, e.g., vegetarians
  • History of drugs and alcohol addiction or excessive alcohol consumption (> 35 g/day)
  • Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except oral contraceptives or cases which, based on drug's or metabolite's half-life, complete elimination can be assumed
  • Hospitalization for any reasons up to 8 weeks before trial
  • Treatment, within 6 months before the trial, with any drugs with known and well-established toxic potential to major organs
  • Participation in any other experimental research or administration of any experimental drug within 6 months before this trial
  • Donation or loss of 450 mL or more of blood within 3 months before this trial or 3 donations (women)/4 donations (men) of blood within 12 months before this trial
  • Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial
  • Pregnancy, labor or miscarriage with 12 weeks before admission predicted date.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Zolpidem 1.75 mg
Zolpidem Hemitartarate 1.75 mg Orodispersible Tablets Once daily
Drug: Zolpidem Hemitartarate
Experimental: Zolpidem 3.50 mg
Zolpidem Hemitartarate 3.50 mg Orodispersible Tablets Once daily
Drug: Zolpidem Hemitartarate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Half-life (t1/2)
Time Frame: 24 hours
24 hours
Area under the curve(0-last)
Time Frame: 24 hours
24 hours
Area under the curve(0-all)
Time Frame: 24 hours
24 hours
Area under the curve(0-inf)
Time Frame: 24 hours
24 hours
Elimination rate constant (Ke)
Time Frame: 24 hours
24 hours
Maximum serum concentration (Cmax)
Time Frame: 24 hours
24 hours
Time to reach maximum (peak) plasma concentration following drug administration (tmax)
Time Frame: 24 hours
24 hours
Time of the last measurable (positive) concentration (tlast)
Time Frame: 24 hours
24 hours
Area under the first moment of the plasma concentration-time curve extrapolated from time zero to infinity as a percentage of total AUC
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of adverse events
Time Frame: 60 days
60 days
Intensity of adverse events
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biolab Sanus Farmaceutica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GDN 057/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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