Clinical trial NCT02814058: Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 1.75 mg Formulation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
Healthy Volunteers
Lead sponsor: Biolab Sanus Farmaceutica
Sponsor class: INDUSTRY
First posted: 2016-06-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve (0-last)
timeFrame: 24 hours
measure: Area under the curve (0-inf)
timeFrame: 24 hours
measure: Half life (t1/2)
timeFrame: 24 hours
measure: Elimination rate constant (Ke)
timeFrame: 24 hours
measure: Maximum serum concentration (Cmax)
timeFrame: 24 hours
measure: Time to reach maximum (peak) plasma concentration following drug administration (tmax)
timeFrame: 24 hours
measure: Volume of distribution (Vd)
timeFrame: 24 hours
measure: Clearance (C)
timeFrame: 24 hours
Secondary outcomes:
measure: Number of adverse events
timeFrame: 60 days
measure: Intensity of adverse events
timeFrame: 60 days
Other outcomes:
Locations:
city: Bragança Paulista
country: Brazil
facility: UNIFAG - Unidade Integrada de Farmacologia e Gastroenterologia
state: SP
Study officials:
affiliation: UNIFAG - Unidade Integrada de Farmacologia e Gastroenterologia
name: José Pedrazzoli Júnior, PhD
role: PRINCIPAL_INVESTIGATOR
References: