HealthyNCT00779441
Bioequivalence Study of Zolpidem 10 mg Tablets Under Fed Conditions
A study testing Zolpidem 10mg tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial summary
The study compared the relative bioavailability (rate and extent of absorption) of 10 mg Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult volunteers administered under non-fasting 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
- What is being tested?
- Zolpidem 10mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Nov 2005
- Phase
- Interventional
- 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
- Healthy men or women 18 years of age or older at the time of dosing
- Weights within ±20% for height and body frame as per Desirable weight for adults(1983 Metropolitan Height and Weight table)
- Volunteers judged by the investigator to be healthy based on their medical and medication history, physical examination, electrocardiogram, and clinical laboratory results
- Volunteers willing to participate in the study and have signed a copy of written consent form
- If female:
- Of childbearing potential, was practicing an acceptable method of birth control for the duration of study as judged b y the investigator(s), such as condom with spermicide, intrauterine device (IUD), or abstinence; or Was menopausal for at least 1year; or Was surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Who cannot join
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- Volunteers with a recent history of drug or alcohol addiction or abuse
- Volunteers with the presence of clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators)
- Volunteers with clinical laboratory test values outside the accepted reference range and, when confirmed on re-examination, were deemed to by clinically significant
- Volunteers with a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
- Volunteers with positive drug abuse screen when screened for the study
Show all 16Show fewer
- Female volunteers demonstrating a positive pregnancy screen
- Female volunteers who are currently breast feeding
- Volunteers with a history of clinically significant allergies including the allergies
- Volunteers with any clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigation)
- Volunteers who currently use tobacco products
- Volunteers who had taken any drug known to induce metabolism or inhibit hepatic metabolism in the 28 days prior to the period I dosing.
- Volunteers who reported donating greater than 150 mL of blood within 28 days prior to period I dosing. All subjects were advised not to donate plasma for four weeks after completing the study
- Volunteers who had donated plasma (e.g. plasmapheresis) within 14 days prior to period I dosing. All subjects were advised not to donate plasma for four weeks after completing o the study
- Volunteers who reported receiving any investigational drug within 28 days prior to period I dosing
- Volunteers who reported taking any systemic prescription 14 days prior to Period I dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Relative Bioavailability Study of 10 mg Zolpidem Tablet Under Non-Fasting Conditions
The study compared the relative bioavailability (rate and extent of absorption) of 10 mg Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult volunteers administered under non-fasting conditions
Read the detailed description
This was a single-center, randomized, open label, two-way cross over study conducted under non-fasting conditions. Subjects checked into the clinical facility the day prior to dosing at least 10 hours prior to dose administration. On study day 1, subjects were dosed with single oral dose (1x10mg tablet) of the test and reference products thirty minutes after initiation of a standardized, high fat breakfast which was preceded by an overnight fast. Following a seven day wash out period, subjects returned and were dosed with an alternative treatment as per randomization Thirty-six (N=36) volunteers were enrolled in the study of which 17 were females and 19 were males. Subject 22 was dropped from further study participation prior to period II check in due to adverse events
- Conditions
- Healthy
- Being tested
- Zolpidem 10mg tablets
- Keywords
- Bioequivalence zolpidem 10mg tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolpidem 10mg tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Zolpidem 10mg tablets of ranbaxy Receives: Drug: Zolpidem 10mg tablets |
| 2 | Active comparator | Ambien® 10mg tablets Receives: Drug: Zolpidem 10mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startAug 2005
- Primary completionSep 2005
- Study completionNov 2005
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779441
- Sponsor's protocol ID
- R05-275
- Status last verified
- Oct 2008
- First submitted
- 23 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Relative Bioavailability Study of 10 mg Zolpidem Tablet Under Non-Fasting Conditions
- ClinicalTrials.gov ID
- NCT00779441
- Acronym / sponsor ID
- R05-275
- Conditions
- Healthy
- Keywords
- Bioequivalence zolpidem 10mg tablets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 24 Oct 2008 (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 study compared the relative bioavailability (rate and extent of absorption) of 10 mg Zolpidem tablets by Ohm Laboratories Inc. with that of 10 mg Ambien® tablets distributed by Sanofi-Synthelabo, Inc. following single oral dose (1x10 mg tablet) in healthy adult volunteers administered under non-fasting conditions
Detailed description
This was a single-center, randomized, open label, two-way cross over study conducted under non-fasting conditions. Subjects checked into the clinical facility the day prior to dosing at least 10 hours prior to dose administration. On study day 1, subjects were dosed with single oral dose (1x10mg tablet) of the test and reference products thirty minutes after initiation of a standardized, high fat breakfast which was preceded by an overnight fast. Following a seven day wash out period, subjects returned and were dosed with an alternative treatment as per randomization Thirty-six (N=36) volunteers were enrolled in the study of which 17 were females and 19 were males. Subject 22 was dropped from further study participation prior to period II check in due to adverse events
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Zolpidem 10mg tabletsZolpidem 10mg tablets of ranbaxy |
| 2 | Active comparator | Drug: Zolpidem 10mg tabletsAmbien® 10mg tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy men or women 18 years of age or older at the time of dosing
- Weights within ±20% for height and body frame as per Desirable weight for adults(1983 Metropolitan Height and Weight table)
- Volunteers judged by the investigator to be healthy based on their medical and medication history, physical examination, electrocardiogram, and clinical laboratory results
- Volunteers willing to participate in the study and have signed a copy of written consent form
- If female:
Key exclusion criteria (16 listed)
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- Volunteers with a recent history of drug or alcohol addiction or abuse
- Volunteers with the presence of clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators)
- Volunteers with clinical laboratory test values outside the accepted reference range and, when confirmed on re-examination, were deemed to by clinically significant
- Volunteers with a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
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 10mg tablets | Drug | 1, 2 |
Primary outcome
Bioequivalence
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 24 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zolpidem 10mg tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
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 6 inclusion and 16 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 24 Oct 2008. 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 United States. 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.
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?
Bioequivalence. 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 24 Oct 2008.