Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation

NCT02817750 | Completed Phase 1

• 1 other identifier: JPJ 16/16
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

volunteers; Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Area under the curve (0-last)

  24 hours

• Area under the curve (0-inf)

  24 hours

• Half life (t1/2)

  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

• Volume of distribution (Vd)

  24 hours

• Clearance (C)

  24 hours

Secondary Outcomes (2)

• Number of adverse events

  60 days

• Intensity of adverse events

  60 days

Study Arms (2)

zolpidem hemitartarate (fasting + post-prandial)

EXPERIMENTAL

zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial

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

zolpidem hemitartarate (post-prandial + fasting)

EXPERIMENTAL

zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting

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

Interventions

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

zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial

zolpidem hemitartarate (fasting + post-prandial)

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

zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting

zolpidem hemitartarate (post-prandial + fasting)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biolab Sanus Farmaceutica: lead

Study Sites (1)

UNIFAG - Unidade Integrada de Farmacologia e Gastroenterologia

Bragança Paulista, São Paulo, 12916-900, Brazil

Location

MeSH Terms

Interventions

Postprandial Period

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• José Pedrazzoli Júnior, PhD

  UNIFAG - Universidade Integrada de Farmacologia e Gastroenterologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: July 5, 2017
• Primary Completion: February 22, 2018
• Study Completion: February 22, 2018
• Last Updated: June 11, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)