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Bioequivalence Study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions

Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Citalopram Hydrobromide (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Benoit Girard, M.D, Principal Investigator, Affiliation: Anapharm. Clinical Laboratory

Summary

This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr. Reddy's Laboratories Limited under fasting conditions.

Clinical Details

Official title: Randomized, 2-way Crossover, Bioequivalence Study of Citalopram Hydrobromide 40 mg Tablets and Celexa 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fasting Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence based on Cmax and AUC parameters

Detailed description: randomized, 2-way crossover; bioequivalence study of citalopram hydrobromide 40mg tablets and celexa 40 mg tablets administered as 1 x 40 mg tablet in healthy subjects under fasting conditions

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e. g. radio, newspaper, Anapharm Inc. Web site, Anaphann Inc. volunteers' data base). Subjects must meet all of the following criteria in order to be included in the study:

- Non-child-bearing potential female or male, smokers and/or non-smoker, 18 years of

age and older.

- Subjects capable of consentW

- Non-child-bearing potential female subject:

- Post-menopausal state: absence of menses for 12 months prior to drug administration

or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration.

- Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least

6 months prior to drug administration. Exclusion Criteria:

- Subjects to whom any of the following applies will be excluded from the study:

- Clinically significant illnesses within 4 weeks prior to the administration of

the study medication.

- Clinically significant surgery within 4 weeks prior to the administration of the

study medication.

- Any clinically significant abnormality found during medical screening.

- Any reason which, in the opinion of the Medical Sub-Investigator, would prevent

the subject from participating in the study.

- Abnormal laboratory tests judged clinically significant.

- Positive urine drug screen at screening.

- Positive testing for hepatitis B, hepatitis C, or Human Immunodeficiency

Virus(HIV)at screening.

- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic

blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm)at screening.

- Subjects with Body Mass Index (BMI) 2: 30. 0.

- History of significant alcohol abuse within six months prior to the screening

visit or any indication of the regular use of more than fourteen units of alcohol per week (1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).

- History of drug abuse or use of illegal drugs: use of soft drugs (such as

marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP]and crack) within 1 year prior to the screening visit.

- History of allergic reactions to citalopram hydrobromide or other related drugs.

- History of allergic reactions to heparin.

- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of

inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, Mono Amine Oxidase (MAO) inhibitors, neuroleptics,verapamil, quinidine)within 30 days prior to administration of the study medication.

- Use of an investigational drug or participation in an investigational study

within 30 days prior to administration of the study medication.

- Clinically significant history or presence of any clinically significant

gastrointestinal pathology (e. g. chronic diarrhea, inflammatory bowel diseases). Unresolved gastrointestinal symptoms (e. g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.

- Any clinically significant history or presence of clinically significant

neurological,endocrinal,cardiovascular,pulmonary,hematologic,immunologic, psychiatric or metabolic disease.

- Use of prescription medication (including hormone therapy)within 14 days prior

to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.

- Smoking more than 25 cigarettes per day.

- Any food allergy, intolerance, restriction or special diet that could, in the

opinion of the Medical Sub-Investigator, contraindicate the subject's participation in this study.

- A depot injection or an implant of any drug within 3 months prior to

administration of study medication.

- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation

or loss of whole blood prior to administration of the study medication as follows:

- less than 300 mL of whole blood within 30 days,

- 300 mL to 500 mL of whole blood within 45 days or

- more than 500 mL of whole blood within 56 days prior to drug administration.

- Consumption of food or beverages containing grapefruit (e. g. fresh, canned. or

frozen)within 7 days prior to administration of the study medication.

- History of seizure disorder or bipolar affective disorder.

- Active psychiatric diagnosis.

Locations and Contacts

Anapharm, Quebec, Canada
Additional Information

Starting date: October 2003
Last updated: June 23, 2010

Page last updated: August 23, 2015

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