HealthyPhase 1NCT00940238
Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Under Fasting Condition
A Phase 1 study testing Citalopram Hydrobromide 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 Citalopram Hydrobromide Tablets 40 mg: Test Product: Citalopram Hydrobromide Tablets 40 mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: CelexaTM Tablets 40 mg (Reference Listed Drug) manufactured by Forest Pharmaceuticals 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?
- Citalopram Hydrobromide
- How many people
- Not given
- Where
- 1 siteIndia
- 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 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 the weight range as related to height, as per the Life Insurance Corporation (LIC) Chart (Appendix A).
- No abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate and body temperature) hematological tests, serum chemistry, urinalysis, ECG and Chest X-ray. Subjects having values above/below the reference range, (Appendix J) for hematological, serum chemistry and urinanalysis values, will be clinically correlated for signs and symptoms. These subjects will be included if found asymptomatic.
- Willingness to follow, the protocol requirements, as evidenced by written, informed consent.
- Agreeing to, not to use any medication (prescription and over the counter), including vitamins and minerals for 15 days prior to study \& during the course of the study.
- No history or presence of significant alcoholism or drug abuse in the past one year.
- Subjects should preferably be non-smokers. If moderate smokers are included (less than 10 cigarette per day) as per guidelines will be identified as such and documented in the history taking form in CRF.
Who cannot join
- Requiring medication for any ailment.
- 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 or psychiatric diseases.
- Participation in a clinical drug study or Bioequivalence study 90 days prior to present study.
- History of malignancy or other serious diseases.
- Refusal to abstain from food for ten (10) hours prior to study drug administration on first day of each study period and for four (4) additional hours each, post dose.
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- Refusal to abstain from water for one (1) hour prior to study drug administration on first day of each study period and for one (1) additional hour, post dosing.
- Any contraindication to blood sampling.
- Smoking or consumption of tobacco products during the study.
- Use of xanthine-containing beverages or food for 48 hours prior to each drug dose.
- Blood donation 30 days prior to the commencement of the study.
- Subjects with positive HIV tests.
- Subjects with positive HbsAg or Hepatitis-C tests.
- Known history of hypersensitivity Citalopram or related drugs.
- Pregnant and lactating women. At the time of screening, prior to enrollment, presence of pregnancy will be confirmed by urine pregnancy test.Just prior to commencement of study (for both periods), presence of pregnancy will be confirmed by urine pregnancy test.
- Female subjects not confirm 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.
- History of drug abuse in the past one year.
Trial locations and contacts
1 site in 1 country.
India1 site
Accutest Research Laboratories Pvt. Ltd.
Mumbai, Maharashtra, 400 709
About this study
Official title: A Randomized, Single Dose, Open Label, Bioequivalence Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Under Fasting Condition
- Objective:
- To compare the rate and extent of absorption of Citalopram Hydrobromide Tablets 40 mg: Test Product: Citalopram Hydrobromide Tablets 40 mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: CelexaTM Tablets 40 mg (Reference Listed Drug) manufactured by Forest Pharmaceuticals Inc., Missouri under fasting conditions in 36 healthy, adult, human subjects in a randomized crossover study.
- Study Design:
- Open-label, randomized, two period crossover studies in 36(Fasting)healthy, normal subjects to compare the single dose bioavailability of Torrent's Citalopram Hydrobromide tablets 40 mg and Forest Pharmaceutical's Celexa 40mg tablets.
- Conditions
- Healthy
- Being tested
- Citalopram Hydrobromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram HydrobromideDrug
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 posted15 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
- NCT00940238
- Sponsor's protocol ID
- US/05/001
- Status last verified
- Oct 2017
- First submitted
- 13 Jul 2009
- Last updated
- 24 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Dose, Open Label, Bioequivalence Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT00940238
- Acronym / sponsor ID
- US/05/001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- First posted
- 15 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 Citalopram Hydrobromide Tablets 40 mg: Test Product: Citalopram Hydrobromide Tablets 40 mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: CelexaTM Tablets 40 mg (Reference Listed Drug) manufactured by Forest Pharmaceuticals Inc., Missouri under fasting conditions in 36 healthy, adult, human subjects in a randomized crossover study.
- Study Design:
- Open-label, randomized, two period crossover studies in 36(Fasting)healthy, normal subjects to compare the single dose bioavailability of Torrent's Citalopram Hydrobromide tablets 40 mg and Forest Pharmaceutical's Celexa 40mg tablets.
Study design
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female subjects in the range of 18 - 45 years of age.
- Body weight within ± 15% of the weight range as related to height, as per the Life Insurance Corporation (LIC) Chart (Appendix A).
- No abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate and body temperature) hematological tests, serum chemistry, urinalysis, ECG and Chest X-ray. Subjects having values above/below the reference range, (Appendix J) for hematological, serum chemistry and urinanalysis values, will be clinically correlated for signs and symptoms. These subjects will be included if found asymptomatic.
- Willingness to follow, the protocol requirements, as evidenced by written, informed consent.
- Agreeing to, not to use any medication (prescription and over the counter), including vitamins and minerals for 15 days prior to study \& during the course of the study.
Key exclusion criteria (18 listed)
- Requiring medication for any ailment.
- 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 or psychiatric diseases.
- Participation in a clinical drug study or Bioequivalence study 90 days prior to present study.
- History of malignancy or other serious diseases.
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 |
|---|---|---|
| Citalopram Hydrobromide | Drug | – |
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 2017.
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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 Citalopram Hydrobromide 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 7 inclusion and 18 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 2017. 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?
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 2017.