Clinical Trials Logo
  1. Home
  2. FED
  3. NCT01503450

Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition

Fed Clinical Trial

Official title:
An Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Bioequivalence Study of Olanzapine 5 mg OD Tablets With Zyprexa Zydis 5 mg Tablets in Healthy Subjects Under Fed Conditions

Clinical Trial Summary

The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fed conditions and to monitor adverse events and ensure safety of subjects.

Clinical Trial Description

An open label, balanced, randomized, two treatment, two-sequence, two-period, single-dose, crossover comparative bioequivalence study of Olanzapine 5 mg OD Tablets, of Dr. Reddy's Laboratories Limited and Zyprexa Zydis 5 mg Tablets of Cardinal Health in healthy, human subjects under fed conditions. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01503450
Study type Interventional
Source Dr. Reddy's Laboratories Limited
Contact
Status Completed
Phase Phase 1
Start date November 2006
Completion date December 2006
View Details
See also
  Status Clinical Trial Phase
Completed NCT01827878 - Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fed Conditions Phase 1
Completed NCT01721187 - Satiety Effects on the Neural Valuation of Food N/A
Completed NCT01372306 - Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition Phase 1
Completed NCT01283932 - Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fed Condition Phase 1
Completed NCT03390881 - Use of Breath Acetone aa a Marker of Energy Balance N/A
Completed NCT01283867 - Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Non-Fasting Conditions Phase 1
Completed NCT01735383 - Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fed Condition Phase 1
Completed NCT01618760 - Bioequivalence Study of Risperidone Tablet 1 mg Under Fed Condition Phase 1
Completed NCT01578265 - Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition Phase 1
Recruiting NCT05837572 - Development of the Leeds Food Preference Questionnaire in Spanish N/A
Completed NCT01618825 - Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition Phase 1
Completed NCT01505998 - Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions Phase 1
Completed NCT01735344 - Bioequivalence Study of Lisinopril Tablets 40 mg Under Fed Condition Phase 1
Completed NCT01372358 - Bioavailability Study of Ciprofloxacin 1000 mg ER Tablets of Dr. Reddy's Under Non-Fasting Conditions Phase 1
Completed NCT01567501 - Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition Phase 1
Completed NCT05995119 - Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy Volunteers Early Phase 1
Completed NCT01314352 - Bioavailability Study of Desloratadine 5 mg Tablet of Dr. Reddy's Under Fed Conditions Phase 1
Completed NCT01744873 - Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition Phase 1
Completed NCT01503424 - Bioequivalence Study of Olanzapine Tablets, 5 mg Under Fed Study Phase 1
Completed NCT01884909 - Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fed Conditions Phase 1