Pharmacokinetics of Zolpidem Orodispersible Tablet

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• Status: Withdrawn
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Zolpidem Hemitartarate

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Half-life (t1/2)	24 hours
Area under the curve(0-last)	24 hours
Area under the curve(0-all)	24 hours
Area under the curve(0-inf)	24 hours
Elimination rate constant (Ke)	24 hours
Maximum serum concentration (Cmax)	24 hours
Time to reach maximum (peak) plasma concentration following drug administration (tmax)	24 hours
Time of the last measurable (positive) concentration (tlast)	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	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events	60 days
Intensity of adverse events	60 days

Collaborators and Investigators

• Sponsor: Biolab Sanus Farmaceutica

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: GDN 057/15