HealthyPhase 1NCT00939536
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fasted Conditions
A Phase 1 study testing Zolpidem Tartrate Tablets 10 mg in people with Healthy, run by Torrent Pharmaceuticals Limited at 1 site in India.
Trial summary
Objective: To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: Ambien® Tablets 10 mg (Reference Listed Drug) manufactured by Sanofi- Synthelabo Inc. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Healthy
- What is being tested?
- Zolpidem Tartrate Tablets 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2005to Jul 2005
- 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 to 45 years
- All sexes
- Adult
Who may be able to join
- Male and female subjects in the range of 18 - 45 years of age.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart. (Appendix A)
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and body temperature)
- Subjects with normal findings as determined by hematological tests, serum chemistry, urine analysis, ECG and X-ray.
- Willingness to follow the protocol requirement as evidenced by written, informed consent.
- Agreeing to, not using any medication (prescription and over the counter), including vitamins and minerals for 15 days prior to study and during the course of the study.
- No history or presence of significant alcoholism or drug abuse in the past one year.
- Non-smokers, ex smokers and light smokers will be included. "Light smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers as someone who completely stopped smoking for at least 3 months.
Who cannot join
- Requiring medication for any ailment including enzyme-modifying drugs Use of any drugs known to induce or inhibit hepatic drug metabolism (e.g.s, inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: SSRIs, cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic diseases.
- History of psychiatric disorder or history of suicide attempt.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
- History of malignancy or other serious diseases.
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- Refusal to abstain from food for ten (10) hours prior to study drug administration the day of each study period and for four (4) additional hours each, post dose.
- Refusal to abstain from water for one (1) hour prior to study drug administration the day of each study period and for two (2) additional hour, post dosing.
- Any contraindication to blood sampling.
- Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period. Habituation of tobacco necessitating uninterrupted tobacco consumption.
- Use of xanthine-containing beverages or food for 48 hours prior to each drug dose.
- Blood donation 90 days prior to the commencement of the study.
- Subjects with positive HIV tests, HbsAg or Hepatitis-C tests.
- Known history of allergic reactions to zolpidem or other related drugs.
- History of drug abuse in the past one year.
- Use of prescription medication within 14 days prior to administration of study medication or over the counter products (including natural food supplements, vitamins, garlic as a supplement) within 2 weeks prior to administration of study medication, except for topical products without systemic absorption.
- Pregnant and lactating women.
- At the time of screening, prior to enrollment, presence of pregnancy will be confirmed by urine pregnancy test.
- Female subjects not confirming to using birth control measures, from the date of screening till the completion of the second period of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable. Use of hormonal contraceptives either oral or implants will not be acceptable.
- Female subjects whose menstruation cycle coincides with the study periods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studies in Fasted Healthy, Normal Subjects to Compare the Single Dose Bio-availability of Torrent's Zolpidem Tartrate Tablets 10 mg and Sanofi-Synthelabo's Ambien® 10 mg Tablets
- Objective:
- To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: Ambien® Tablets 10 mg (Reference Listed Drug) manufactured by Sanofi- Synthelabo Inc. under fasting conditions in 24 healthy, adult, human subjects.
- Study Design:
- Open label, randomized, two-period, two-treatment, two-sequence single dose crossover design.
Read the detailed description
Open label, randomized, two-period, two-treatment, two-sequence single dose
- Conditions
- Healthy
- Being tested
- Zolpidem Tartrate Tablets 10 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolpidem Tartrate Tablets 10 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Torrent's Zolpidem Tartrate Tablets 10 mg | Experimental | Normal Healthy Human Subjects receiving Torrent's Zolpidem Tartrate Tablets 10 mg Receives: Drug: Zolpidem Tartrate Tablets 10 mg |
| Sanofi-Synthelabo's Ambien® 10 mg Tablets | Active comparator | Normal Healthy Human Subjects receiving Sanofi-Synthelabo's Ambien® 10 mg Tablets Receives: Drug: Zolpidem Tartrate Tablets 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that the drug reaches in the plasma
Measured: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)
Measured: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
The area under the 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: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startJun 2005
- Primary completionJun 2005
- Study completionJul 2005
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939536
- Sponsor's protocol ID
- US/05/003
- Status last verified
- Aug 2013
- First submitted
- 13 Jul 2009
- Last updated
- 22 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies in Fasted Healthy, Normal Subjects to Compare the Single Dose Bio-availability of Torrent's Zolpidem Tartrate Tablets 10 mg and Sanofi-Synthelabo's Ambien® 10 mg Tablets
- ClinicalTrials.gov ID
- NCT00939536
- Acronym / sponsor ID
- US/05/003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Posted 22 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Objective:
- To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: Ambien® Tablets 10 mg (Reference Listed Drug) manufactured by Sanofi- Synthelabo Inc. under fasting conditions in 24 healthy, adult, human subjects.
- Study Design:
- Open label, randomized, two-period, two-treatment, two-sequence single dose crossover design.
Detailed description
Open label, randomized, two-period, two-treatment, two-sequence single dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Torrent's Zolpidem Tartrate Tablets 10 mg | Experimental | Drug: Zolpidem Tartrate Tablets 10 mgNormal Healthy Human Subjects receiving Torrent's Zolpidem Tartrate Tablets 10 mg |
| Sanofi-Synthelabo's Ambien® 10 mg Tablets | Active comparator | Drug: Zolpidem Tartrate Tablets 10 mgNormal Healthy Human Subjects receiving Sanofi-Synthelabo's Ambien® 10 mg Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female subjects in the range of 18 - 45 years of age.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart. (Appendix A)
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and body temperature)
- Subjects with normal findings as determined by hematological tests, serum chemistry, urine analysis, ECG and X-ray.
- Willingness to follow the protocol requirement as evidenced by written, informed consent.
Key exclusion criteria (20 listed)
- Requiring medication for any ailment including enzyme-modifying drugs Use of any drugs known to induce or inhibit hepatic drug metabolism (e.g.s, inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: SSRIs, cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic diseases.
- History of psychiatric disorder or history of suicide attempt.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
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 Tablets 10 mg | Drug | Sanofi-Synthelabo's Ambien® 10 mg Tablets, Torrent's Zolpidem Tartrate Tablets 10 mg |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.
The maximum or peak concentration that the drug reaches in the plasma
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
Time frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
Time frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.
The area under the 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 22 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Phase 1 study testing Zolpidem Tartrate Tablets 10 mg in people with Healthy, run by Torrent Pharmaceuticals Limited at 1 site in India.
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 8 inclusion and 20 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 22 Oct 2013. 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 India. 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?
Yes. Results are posted in the registry (first posted 22 Oct 2013). 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) (time frame: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.). 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 22 Oct 2013.