HealthyPhase 1NCT00946036
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fed Conditions
A Phase 1 study testing Sertraline Hydrochloride in people with Healthy, run by Torrent Pharmaceuticals Limited at 1 site in Canada.
Trial summary
Objective: To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions. Study Design: Single-dose, open-label, randomized two-way crossover. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy
- What is being tested?
- Sertraline Hydrochloride
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- 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 Any age
- Child, Adult, Older adult
Who may be able to join
- Male or female, smoker or non smoker, 18 years of age and older.
- Capable of consent.
- BMI>= 19.0 and <30.0 kg/m2
Who cannot join
- Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication.
- Positive testing for hepatitis B, hepatitis C, or HIV at screening.
- ECG abnormalities or vital sign abnormalities(blood pressure).
- History of significant alcohol or drug abuse within one year prior to the screening visit.
- History or allergic reactions to heparin, sertraline or other related drugs.
- Use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication.
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- Clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
- History of seizures, suicide attempt, bipolar disorder or manic episodes.
- Depot injection or an implant of any drugs with in 6 months prior to administration of study medication.
- Breastfeeding subject.
- Positive urine pregnancy test at screening.
- Female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration. Acceptable methods of contraception:
- Intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration)
- Condom or diaphragm + spermicide.
Trial locations and contacts
1 site in 1 country.
About this study
- Objective:
- To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions.
- Study Design:
- Single-dose, open-label, randomized two-way crossover.
- Conditions
- Healthy
- Being tested
- Sertraline Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertraline HydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
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
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946036
- Sponsor's protocol ID
- 40486
- Status last verified
- Jul 2009
- First submitted
- 22 Jul 2009
- Last updated
- 24 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT00946036
- Acronym / sponsor ID
- 40486
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- First posted
- 24 Jul 2009 (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.
- Objective:
- To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions.
- Study Design:
- Single-dose, open-label, randomized two-way crossover.
Study design
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, smoker or non smoker, 18 years of age and older.
- Capable of consent.
- BMI>= 19.0 and <30.0 kg/m2
Key exclusion criteria (14 listed)
- Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication.
- Positive testing for hepatitis B, hepatitis C, or HIV at screening.
- ECG abnormalities or vital sign abnormalities(blood pressure).
- History of significant alcohol or drug abuse within one year prior to the screening visit.
- History or allergic reactions to heparin, sertraline or other related drugs.
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 |
|---|---|---|
| Sertraline Hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 Jul 2009.
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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 Sertraline Hydrochloride in people with Healthy, run by Torrent Pharmaceuticals Limited at 1 site in Canada.
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 3 inclusion and 14 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 Jul 2009. 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 Canada. 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.
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 Jul 2009.