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Pharmacokinetics of Zolpidem Orodispersible Tablet

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. Identifier: NCT02607696
Recruitment Status : Withdrawn
First Posted : November 18, 2015
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Biolab Sanus Farmaceutica

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Zolpidem Hemitartarate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Study Start Date : May 2016
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Area under the curve(0-last) [ Time Frame: 24 hours ]
  2. Area under the curve(0-all) [ Time Frame: 24 hours ]
  3. Area under the curve(0-inf) [ Time Frame: 24 hours ]
  4. Half-life (t1/2) [ Time Frame: 24 hours ]
  5. Elimination rate constant (Ke) [ Time Frame: 24 hours ]
  6. Maximum serum concentration (Cmax) [ Time Frame: 24 hours ]
  7. Time to reach maximum (peak) plasma concentration following drug administration (tmax) [ Time Frame: 24 hours ]
  8. Time of the last measurable (positive) concentration (tlast) [ Time Frame: 24 hours ]
  9. 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 ]

Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: 60 days ]
  2. Intensity of adverse events [ Time Frame: 60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02607696

Sponsors and Collaborators
Biolab Sanus Farmaceutica
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Principal Investigator: Gilberto De Nucci, PhD Galeno Desenvolvimento de Pesquisas Ltda.

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Responsible Party: Biolab Sanus Farmaceutica Identifier: NCT02607696     History of Changes
Other Study ID Numbers: GDN 057/15
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action