Bioequivalence Study of Escitalopram Tablets 10 mg

NCT ID: NCT01745601

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-04
• Study Completion Date: 2010-05-19

Brief Summary

The objective of this study was to confirm if two formulations of escitalopram tablets are bioequivalent.

Test product was escitalopram (10 mg; GlaxoSmithKline) and reference product Lexapro® (10 mg escitalopram; Lundbeck). The single dosage was one tablet.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 26 healthy volunteers, male adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A(reference)/B(test)

initial administration of reference and cross-over to test

Group Type: EXPERIMENTAL

escitalopram 10 mg

Intervention Type: DRUG

Reference product

escitalopram 10 mg

Intervention Type: DRUG

Test product

B(test)/A(reference)

initial administration of test and cross-over to reference

Group Type: EXPERIMENTAL

escitalopram 10 mg

Intervention Type: DRUG

Reference product

escitalopram 10 mg

Intervention Type: DRUG

Test product

Interventions

escitalopram 10 mg

Reference product

Intervention Type: DRUG

escitalopram 10 mg

Test product

Intervention Type: DRUG

Other Intervention Names

Lexapro® LUNDBECK MEXICO SA de CV; escitalopram GLAXOSMITHKLINE MEXICO SA de CV

Eligibility Criteria

Inclusion Criteria

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Males between 18 and 50 years. Body Mass Index between 18 and 27.5 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram)

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.

Hospitalization for any cause in the seven months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any medication, substance, or food. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss => 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.

Reference Type: BACKGROUND

Other Identifiers

117003

Identifier Type: -

Identifier Source: org_study_id