Pharmacokinetics of Zolpidem Orodispersible Tablet
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|ClinicalTrials.gov Identifier: NCT02607696|
Recruitment Status : Withdrawn
First Posted : November 18, 2015
Last Update Posted : February 1, 2017
This is a Phase I, open-label, randomized trial to evaluate the single-dose pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg). Sample size is 48 participants, male or female, aged above 18 years-old.
Primary objective is to evaluate pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg), and secondary objective is to evaluate safety and tolerability of the investigational product.
Participants will be admitted for a period of 36 hours, when investigational product will be administered, and blood samples, at pre-determined time periods, will be collected for pharmacokinetics.
Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Zolpidem Hemitartarate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Randomized Clinical Trial of Evaluation of Zolpidem Hemitartarate Pharmacokinetics (Orodispersible Tablet 1.75 mg and 3.50 mg) After Single Dose Oral Administration in Male and Female Healthy Subjects|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||October 2016|
Experimental: Zolpidem 1.75 mg
Zolpidem Hemitartarate 1.75 mg Orodispersible Tablets Once daily
Drug: Zolpidem Hemitartarate
Experimental: Zolpidem 3.50 mg
Zolpidem Hemitartarate 3.50 mg Orodispersible Tablets Once daily
Drug: Zolpidem Hemitartarate
- Area under the curve(0-last) [ Time Frame: 24 hours ]
- Area under the curve(0-all) [ Time Frame: 24 hours ]
- Area under the curve(0-inf) [ Time Frame: 24 hours ]
- Half-life (t1/2) [ Time Frame: 24 hours ]
- Elimination rate constant (Ke) [ Time Frame: 24 hours ]
- Maximum serum concentration (Cmax) [ Time Frame: 24 hours ]
- Time to reach maximum (peak) plasma concentration following drug administration (tmax) [ Time Frame: 24 hours ]
- Time of the last measurable (positive) concentration (tlast) [ Time Frame: 24 hours ]
- Area under the first moment of the plasma concentration-time curve extrapolated from time zero to infinity as a percentage of total AUC [ Time Frame: 24 hours ]
- Number of adverse events [ Time Frame: 60 days ]
- Intensity of adverse events [ Time Frame: 60 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607696
|Principal Investigator:||Gilberto De Nucci, PhD||Galeno Desenvolvimento de Pesquisas Ltda.|