Healthy SubjectsPhase 1NCT02965274
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablets Under Fed Conditions
A Phase 1 study testing Torrent's Fluoxetine Tablets and Warner Chilcott LLC's Sarafem Tablet in people with Healthy Subjects, run by Torrent Pharmaceuticals Limited.
Trial summary
Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Torrent's Fluoxetine Tablets and Warner Chilcott LLC's Sarafem Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jan 2014
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex: male
- Age: 18-45 years (inclusive both)
- Volunteer with BMI of 18.5-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- Healthy and willing to participate in the study.
- Volunteer willing to provide written informed consent.
- Non-smokers or smoker who smokes less than 10 cigarettes per day.
Who cannot join
- Inability to communicate or co-operate.
- Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- History of pre-existing bleeding disorder.
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal ECG or Chest X-ray.
- HIV, HCV, HBsAg positive volunteers.
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- History of significant blood loss due to any reason, including blood donation in the past 3 months.
- Participation in any study within past 3 months,
- History of alcohol or drug abuse.
- History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study. Positive to Breath alcohol test.
- Positive to breath alcohol test.
- Volunteer found to be positive for Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
- Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mm Hg or more than 89 mm Hg.
- Pulse rate less than 60/minute or more than 100/minute.
- Oral temperature less than 95°F or more than 98.9°F.
- Respiratory rate less than 10/minute or more than 20/minute.
- History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- Recent History of kidney or liver dysfunction.
- Volunteers suffering from any psychiatric (acute or chronic) disorder.
- Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
About this study
Official title: An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Fluoxetine Tablets 20 mg [Torrent,India] Versus Sarafem 20 mg Tablet [ Warner Chilcott LLC, USA] in Healthy Subjects-Fed Condition.
Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.
Read the detailed description
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Fluoxetine Tablets containing Fluoxetine 20 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Sarafem® 20 mg Tablets containing Fluoxetine 20 mg (Reference, Warner Chilcott LLC, USA) in Healthy Human Volunteers Under Fed Condition.
- Conditions
- Healthy Subjects
- Being tested
- Torrent's Fluoxetine Tablets, Warner Chilcott LLC's Sarafem Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torrent's Fluoxetine TabletsDrug
Warner Chilcott LLC's Sarafem TabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Torrent's Fluoxetine Tablets 20 mg Receives: Drug: Torrent's Fluoxetine Tablets |
| Reference | Active comparator | Warner Chilcott LLC, USA Receives: Drug: Warner Chilcott LLC's Sarafem Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: pre-dose to 72 hours post-dose
AUC
Measured: pre-dose to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965274
- Sponsor's protocol ID
- PK-12-057
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Fluoxetine Tablets 20 mg [Torrent,India] Versus Sarafem 20 mg Tablet [ Warner Chilcott LLC, USA] in Healthy Subjects-Fed Condition.
- ClinicalTrials.gov ID
- NCT02965274
- Acronym / sponsor ID
- PK-12-057
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Nov 2016 (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.
Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.
Detailed description
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Fluoxetine Tablets containing Fluoxetine 20 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Sarafem® 20 mg Tablets containing Fluoxetine 20 mg (Reference, Warner Chilcott LLC, USA) in Healthy Human Volunteers Under Fed Condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Torrent's Fluoxetine TabletsTorrent's Fluoxetine Tablets 20 mg |
| Reference | Active comparator | Drug: Warner Chilcott LLC's Sarafem TabletWarner Chilcott LLC, USA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sex: male
- Age: 18-45 years (inclusive both)
- Volunteer with BMI of 18.5-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- Healthy and willing to participate in the study.
- Volunteer willing to provide written informed consent.
Key exclusion criteria (20 listed)
- Inability to communicate or co-operate.
- Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- History of pre-existing bleeding disorder.
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal ECG or Chest X-ray.
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 |
|---|---|---|
| Torrent's Fluoxetine Tablets | Drug | Test |
| Warner Chilcott LLC's Sarafem Tablet | Drug | Reference |
Primary outcome
Cmax
Time frame: pre-dose to 72 hours post-dose
AUC
Time frame: pre-dose to 72 hours post-dose
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 16 Nov 2016.
- Individual participant dataSharing planned: No
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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 Torrent's Fluoxetine Tablets and Warner Chilcott LLC's Sarafem Tablet in people with Healthy Subjects, run by Torrent Pharmaceuticals Limited.
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 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 16 Nov 2016. 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 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?
Cmax (time frame: pre-dose to 72 hours post-dose). The study lists 2 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 16 Nov 2016.