Overview

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 in Fed Condition

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
- Objective: - The objective of this study is to compare the rate and extent of absorption of the Test Product, Citalopram Hydrobromide 40 mg (Torrent Pharmaceutical Limited) to the Reference Product, RLD Tablets 40 mg (Forest Pharmaceuticals Inc, Missouri) under fed condition - Study Design: - Randomized, Single Dose, Open Label, Non-Replicate, Two-period, Two-treatment, Two- Sequence Crossover Bioequivalence Study comparing Citalopram Hydrobromide Tablets 40 mg (manufactured by Torrent Pharmaceuticals Ltd). With RLD Tablets 40 mg (manufactured by Forest Pharmaceuticals Inc Missouri) in 24+2 normal healthy male subjects with a wash out period of 15 days between the two study periods, in fed condition.
Phase:
Phase 1
Details
Lead Sponsor:
Torrent Pharmaceuticals Limited
Treatments:
Citalopram
Dexetimide
Criteria
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 urine analysis 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:

- 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.