Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation

Biolab Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting)

Drug: zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02817750

JPJ 16/16

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics of the new formulation of zolpidem hemitartarate orodispersible tablet 3.5 mg in male and female healthy volunteers.

Full description

This is a phase I study of zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and postprandial administration. Sample size is 28 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 orodispersible tablet 3.5 mg in fasting (period 1) and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 2) Sequency 2: zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 1) and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting (period 2) Formulation will be administered in a single dose, orally in each period. The 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 3.5 mg in healthy volunteers. As a secondary objective, it will be evaluated if there is any pharmacokinetics difference between genders.

Enrollment

28 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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 or 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

Know 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 as 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 reasons 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 subjects
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