HealthyPhase 1NCT02817750
Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation
A Phase 1 study testing zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial) and zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting) in people with Healthy, run by Biolab Sanus Farmaceutica at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial) and zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jul 2017to 22 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
- Positive results for the detection of abusive drugs at urine exam
- Result higher than 0.1 mg/L for the etilometer exam
- Any condition, according to investigator's best judgment, that prevents the subject to participate in the trial
Trial locations and contacts
1 site in 1 country.
Brazil1 site
UNIFAG - Unidade Integrada de Farmacologia e Gastroenterologia
Bragança Paulista, São Paulo, 12916-900
About this study
Official title: Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation, With Fasting and Postprandial Administration, in Male and Female Healthy Volunteers, Produced by Biolab Sanus Farmacêutica Ltda
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.
Read the detailed description
This is a phase I study of zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and postprandial administration. Sample size is 28 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 orodispersible tablet 3.5 mg in fasting (period 1) and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 2)
- Sequency 2: zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 1) and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting (period 2) Formulation will be administered in a single dose, orally in each period. The 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 3.5 mg in healthy volunteers. As a secondary objective, it will be evaluated if there is any pharmacokinetics difference between genders.
- Conditions
- Healthy
- Being tested
- zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial), zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting)
- Keywords
- volunteers, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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
| Study group | Role | What they receive |
|---|---|---|
| zolpidem hemitartarate (fasting + post-prandial) | Experimental | zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial Receives: 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 Receives: Drug: zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (0-last)
Measured: 24 hours
Area under the curve (0-inf)
Measured: 24 hours
Half life (t1/2)
Measured: 24 hours
Elimination rate constant (Ke)
Measured: 24 hours
Maximum serum concentration (Cmax)
Measured: 24 hours
Time to reach maximum (peak) plasma concentration following drug administration (tmax)
Measured: 24 hours
Volume of distribution (Vd)
Measured: 24 hours
Clearance (C)
Measured: 24 hours
Secondary outcomes (2)
Number of adverse events
Measured: 60 days
Intensity of adverse events
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start5 Jul 2017
- Primary completion22 Feb 2018
- Study completion22 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Pedrazzoli Júnior, PhD, Principal investigator, UNIFAG - Universidade Integrada de Farmacologia e Gastroenterologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817750
- Sponsor's protocol ID
- JPJ 16/16
- Status last verified
- Jul 2017
- First submitted
- 27 Jun 2016
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation, With Fasting and Postprandial Administration, in Male and Female Healthy Volunteers, Produced by Biolab Sanus Farmacêutica Ltda
- ClinicalTrials.gov ID
- NCT02817750
- Acronym / sponsor ID
- JPJ 16/16
- Conditions
- Healthy
- Keywords
- volunteers, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 22 Feb 2018 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase I study of zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and postprandial administration. Sample size is 28 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 orodispersible tablet 3.5 mg in fasting (period 1) and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 2)
- Sequency 2: zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 1) and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting (period 2) Formulation will be administered in a single dose, orally in each period. The 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 3.5 mg in healthy volunteers. As a secondary objective, it will be evaluated if there is any pharmacokinetics difference between genders.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zolpidem hemitartarate (fasting + post-prandial) | Experimental | Drug: zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial)zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial |
| zolpidem hemitartarate (post-prandial + fasting) | Experimental | Drug: zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting)zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial)zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial | Drug | zolpidem hemitartarate (fasting + post-prandial) |
| zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting)zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting | Drug | zolpidem hemitartarate (post-prandial + fasting) |
Primary outcome
Area under the curve (0-last)
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
Volume of distribution (Vd)
Time frame: 24 hours
Clearance (C)
Time frame: 24 hours
2 secondary outcomes
Number of adverse events
Time frame: 60 days
Intensity of adverse events
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Pedrazzoli Júnior, PhD principal investigator
UNIFAG - Universidade Integrada de Farmacologia e Gastroenterologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial) and zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting) in people with Healthy, run by Biolab Sanus Farmaceutica at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (0-last) (time frame: 24 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.