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CompletedNCT00940238Updated Oct 24, 2017

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 interventional study of Citalopram Hydrobromide in Healthy, sponsored by Torrent Pharmaceuticals Limited. Completed at 1 site in India. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-10-24.

Sponsored by Torrent Pharmaceuticals Limited · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Ages
18 Years to 45 Years
Sex
All
01

Study 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., 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.
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Torrent Pharmaceuticals Limited is the lead sponsor of 71 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 1

Interventions

  • DrugCitalopram Hydrobromide
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What researchers measure

Primary outcomes

  1. Bioequivalence

07

Study locations

1 site
  • Accutest Research Laboratories Pvt. Ltd.
    Mumbai, Maharashtra 400 709, India
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00940238
Lead sponsor
Torrent Pharmaceuticals Limited
First posted
Jul 15, 2009
Last update
Oct 24, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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