HealthyPhase 1NCT00658541
Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets
A Phase 1 study testing Zolpidem Tartrate 10 mg tablet and Zolpidem Tartrate 10 mg tablet (Ambien®) in people with Healthy and Therapeutic Equivalency, run by Mutual Pharmaceutical Company, Inc..
Trial summary
The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Therapeutic Equivalency
- What is being tested?
- Zolpidem Tartrate 10 mg tablet and Zolpidem Tartrate 10 mg tablet (Ambien®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- May 2004to May 2004
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Sex: Male or Female; similar proportions of each preferred
- Age: At least 18 years
- Weight: must be 15% of ideal weight for height and frame
- Subjects must be in good health and physical condition as determined by medical history
- Subjects must read and sign the Consent Form
Who cannot join
- history of treatment for alcoholism, substance abuse, or drug abuse within past 24 months
- history of malignancy, stroke, diabetes, cardiac, renal or liver disease
- history of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease
- history of treatment for asthma within the past five (5) years
- history of mental depression, pulmonary disease, sleep apnea
- females who are pregnant or lactating
Show all 12Show fewer
- history of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative
- conditions upon screening which might contraindicate or require that caution be used in the administration of zolpidem tartrate, including sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg; heart rate less than 50 beats per minute after a 5-minute rest in a seated position
- inability to read and/or sign the consent form
- treatment with any other investigation drug during the four (4) weeks prior to the initial dosing for this study
- subjects who have donated blood within four (4) weeks prior to the initial dosing for this study
- subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.) Three (3) months abstinence is required.
About this study
Official title: A Randomized, Two-way Crossover, Single-dose, Open-label Study to Evaluate the Relative Bioequivalence of a Test Tablet Formulation of Zolpidem Tartrate 10mg, Compared to an Equivalent Dose of Ambien® in Fed, Healthy, Adult Subjects
The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.
Read the detailed description
The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.
Thirty-eight healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zolpidem tartrate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, following an overnight fast of at least 10 hours and a standardized, high fat breakfast, subjects will receive either a single oral dose of the test formulation, zolpidem tartrate (1 x 10 mg tablet) or a single oral dose of the reference formulation, Ambien® (1 x 10 mg tablet). After a 7 day washout period, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 12 hours post dose at times sufficient to adequately define the pharmacokinetics of zolpidem tartrate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and pulse rate will be obtained prior to dosing and at 0.5, 1, 2, 4 and 12 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.
- Conditions
- Healthy, Therapeutic Equivalency
- Being tested
- Zolpidem Tartrate 10 mg tablet, Zolpidem Tartrate 10 mg tablet (Ambien®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolpidem Tartrate 10 mg tabletDrug
10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
Zolpidem Tartrate 10 mg tablet (Ambien®)Drug
Also called Ambien®
10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Zolpidem Tartrate 10 mg Tablets | Experimental | A single dose of zolpidem tartrate 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. Receives: Drug: Zolpidem Tartrate 10 mg tablet |
| Zolpidem Tartrate (Ambien®) 10 mg Tablets | Active comparator | A single dose of Ambien® 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. Receives: Drug: Zolpidem Tartrate 10 mg tablet (Ambien®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate
The maximum or peak concentration that zolpidem tartrate reaches in the plasma.
Measured: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.
Measured: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate
The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant
Measured: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startMay 2004
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658541
- Sponsor's protocol ID
- 04065
- Status last verified
- Apr 2011
- First submitted
- 9 Apr 2008
- Last updated
- 3 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-way Crossover, Single-dose, Open-label Study to Evaluate the Relative Bioequivalence of a Test Tablet Formulation of Zolpidem Tartrate 10mg, Compared to an Equivalent Dose of Ambien® in Fed, Healthy, Adult Subjects
- ClinicalTrials.gov ID
- NCT00658541
- Acronym / sponsor ID
- 04065
- Conditions
- Healthy, Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Posted 20 Jan 2010
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 compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.
Detailed description
The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem tartrate tablets)in adult subjects under fed conditions.
Thirty-eight healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zolpidem tartrate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, following an overnight fast of at least 10 hours and a standardized, high fat breakfast, subjects will receive either a single oral dose of the test formulation, zolpidem tartrate (1 x 10 mg tablet) or a single oral dose of the reference formulation, Ambien® (1 x 10 mg tablet). After a 7 day washout period, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 12 hours post dose at times sufficient to adequately define the pharmacokinetics of zolpidem tartrate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and pulse rate will be obtained prior to dosing and at 0.5, 1, 2, 4 and 12 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zolpidem Tartrate 10 mg Tablets | Experimental | Drug: Zolpidem Tartrate 10 mg tabletA single dose of zolpidem tartrate 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. |
| Zolpidem Tartrate (Ambien®) 10 mg Tablets | Active comparator | Drug: Zolpidem Tartrate 10 mg tablet (Ambien®)A single dose of Ambien® 10 mg administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sex: Male or Female; similar proportions of each preferred
- Age: At least 18 years
- Weight: must be 15% of ideal weight for height and frame
- Subjects must be in good health and physical condition as determined by medical history
- Subjects must read and sign the Consent Form
Key exclusion criteria (12 listed)
- history of treatment for alcoholism, substance abuse, or drug abuse within past 24 months
- history of malignancy, stroke, diabetes, cardiac, renal or liver disease
- history of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease
- history of treatment for asthma within the past five (5) years
- history of mental depression, pulmonary disease, sleep apnea
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 Tartrate 10 mg tablet10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. | Drug | Zolpidem Tartrate 10 mg Tablets |
| Zolpidem Tartrate 10 mg tablet (Ambien®)Also: Ambien®10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast. | Drug | Zolpidem Tartrate (Ambien®) 10 mg Tablets |
Primary outcome
Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate
Time frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
The maximum or peak concentration that zolpidem tartrate reaches in the plasma.
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate
Time frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate
Time frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration
The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.
- Daily Med - Posting of Recently Submitted Labeling to the FDALink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zolpidem Tartrate 10 mg tablet and Zolpidem Tartrate 10 mg tablet (Ambien®) in people with Healthy and Therapeutic Equivalency, run by Mutual Pharmaceutical Company, Inc..
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 5 inclusion and 12 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 3 May 2011. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate (time frame: serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration). The study lists 3 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 3 May 2011.