Healthy VolunteersPhase 1NCT02607696
Pharmacokinetics of Zolpidem Orodispersible Tablet
A Phase 1 study testing Zolpidem Hemitartarate in people with Healthy Volunteers, run by Biolab Sanus Farmaceutica.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Zolpidem Hemitartarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Oct 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
About this study
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
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.
Read more
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.
- Conditions
- Healthy Volunteers
- Being tested
- Zolpidem Hemitartarate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolpidem HemitartarateDrug
| Study group | Role | What they receive |
|---|---|---|
| Zolpidem 1.75 mg | Experimental | Zolpidem Hemitartarate 1.75 mg Orodispersible Tablets Once daily Receives: Drug: Zolpidem Hemitartarate |
| Zolpidem 3.50 mg | Experimental | Zolpidem Hemitartarate 3.50 mg Orodispersible Tablets Once daily Receives: Drug: Zolpidem Hemitartarate |
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-all)
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
Time of the last measurable (positive) concentration (tlast)
Measured: 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
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 posted18 Nov 2015 (estimated)
- Study startMay 2016
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilberto De Nucci, PhD, Principal investigator, Galeno Desenvolvimento de Pesquisas Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607696
- Sponsor's protocol ID
- GDN 057/15
- Status last verified
- Jan 2017
- First submitted
- 16 Nov 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02607696
- Acronym / sponsor ID
- GDN 057/15
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Oct 2016 (estimated)
- First posted
- 18 Nov 2015 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zolpidem 1.75 mg | Experimental | Drug: Zolpidem HemitartarateZolpidem Hemitartarate 1.75 mg Orodispersible Tablets Once daily |
| Zolpidem 3.50 mg | Experimental | Drug: Zolpidem HemitartarateZolpidem Hemitartarate 3.50 mg Orodispersible Tablets Once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
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 | Drug | Zolpidem 1.75 mg, Zolpidem 3.50 mg |
Primary outcome
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
2 secondary outcomes
Number of adverse events
Time frame: 60 days
Intensity of adverse events
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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.
Gilberto De Nucci, PhD principal investigator
Galeno Desenvolvimento de Pesquisas Ltda.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zolpidem Hemitartarate in people with Healthy Volunteers, run by Biolab Sanus Farmaceutica.
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 17 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: withdrawn, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 9 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 1 Feb 2017.