Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 12:15 AM
NCT ID:
NCT02814058
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.
Study:
NCT02814058
Study Brief:
Protocol Section:
NCT02814058