Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 10:17 PM
Study NCT ID:
NCT02814058
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2016-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 1.75 mg Formulation
Sponsor:
Biolab Sanus Farmaceutica
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: