A Phase 1 interventional study of escitalopram 10 mg and escitalopram 10 mg in Anxiety Disorders, sponsored by GlaxoSmithKline. Completed. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-16.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's enrollment of 26 is below the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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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)
Exclusion Criteria:
Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.
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.
initial administration of reference and cross-over to test
Drug: escitalopram 10 mg
initial administration of test and cross-over to reference
Drug: escitalopram 10 mg
Reference product
Also known as: Lexapro® LUNDBECK MEXICO SA de CV
Test product
Also known as: escitalopram GLAXOSMITHKLINE MEXICO SA de CV
Peak Plasma Concentration (CMAX) of escitalopram
Pharmacokinetics
Time frame: 0.0, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 18.0, 22.0, 48.0, 72.0, and 96.0 postdosage
Area under the plasma concentration versus time curve (AUC) of escitalopram
Pharamacokinetics
Time frame: 0.0, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 18.0, 22.0, 48.0, 72.0, and 96.0 postdosage
No study locations are listed for this record.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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