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

NCT01149967 | Completed Phase 1 DMC

• 1 other identifier: 30284
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Bioequivalence; Citalopram; Crossover

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  2 Months

Study Arms (2)

Citalopram

EXPERIMENTAL

Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's

Drug: Citalopram Hydrobromide

Celexa

ACTIVE COMPARATOR

Celexa 40 mg Tablets of Forest Labs

Drug: Citalopram Hydrobromide

Interventions

Citalopram Hydrobromide DRUG

Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited

Also known as: Celexa Tablets 40 mg

Celexa; Citalopram

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Anapharm

Québec, Canada

Location

MeSH Terms

Interventions

Citalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Benoit Girard, M.D

  Anapharm. Clinical Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 24, 2010
• Study Start: October 1, 2003
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: June 24, 2010

Record last verified: 2010-06

Locations

CA (1)