Pharmacokinetics of Zolpidem Orodispersible Tablet

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02607696
• Other study ID #: GDN 057/15
• Status: Withdrawn
• Phase: Phase 1
• First received: November 16, 2015
• Last updated: January 31, 2017
• Start date: May 2016

Study information

• Verified date: January 2017
• Source: Biolab Sanus Farmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female study participants, aged above 18 years-old; women cannot be pregnant or breastfeeding

• Body mass index (BMI) greater than or equal to 19 and less than or equal to 28.75 Kg/m2

• Good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, 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:

• Known hypersensitivity to the investigational product (Zolpidem) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug

• History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism

• Chronic therapy with any drugs, except oral contraceptives

• History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure

• Electrocardiographic findings that, at investigator criteria, are not recommended for study participation

• Deviations on screening laboratory results that are considered as clinically relevant by the researcher

• Smoking

• Intake of more that 5 cups of coffee or tea per day

• Unusual food habits, e.g., vegetarians

• History of drugs and alcohol addiction or excessive alcohol consumption (> 35 g/day)

• Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except oral contraceptives or cases which, based on drug's or metabolite's half-life, complete elimination can be assumed

• Hospitalization for any reasons up to 8 weeks before trial

• Treatment, within 6 months before the trial, with any drugs with known and well-established toxic potential to major organs

• Participation in any other experimental research or administration of any experimental drug within 6 months before this trial

• Donation or loss of 450 mL or more of blood within 3 months before this trial or 3 donations (women)/4 donations (men) of blood within 12 months before this trial

• Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial

• Pregnancy, labor or miscarriage with 12 weeks before admission predicted date.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Zolpidem Hemitartarate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biolab Sanus Farmaceutica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve(0-last)		24 hours
Primary	Area under the curve(0-all)		24 hours
Primary	Area under the curve(0-inf)		24 hours
Primary	Half-life (t1/2)		24 hours
Primary	Elimination rate constant (Ke)		24 hours
Primary	Maximum serum concentration (Cmax)		24 hours
Primary	Time to reach maximum (peak) plasma concentration following drug administration (tmax)		24 hours
Primary	Time of the last measurable (positive) concentration (tlast)		24 hours
Primary	Area under the first moment of the plasma concentration-time curve extrapolated from time zero to infinity as a percentage of total AUC		24 hours
Secondary	Number of adverse events		60 days
Secondary	Intensity of adverse events		60 days