Clinical Trials Logo

Clinical Trial Summary

This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in healthy adult human subjects.


Clinical Trial Description

Objective of this pivotal study was to assess the bioequivalence between Test Product: Metoprolol Succinate 200 mg Ipca Laboratories Limited, India and the corresponding Reference Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 200 mg of Astrazenica LP, USA under fed condition in healthy adult human subjects in a randomized crossover study.

The study was conducted with 48 healthy adult subjects. In each study period, a single 200 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.

The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01884909
Study type Interventional
Source IPCA Laboratories Ltd.
Contact
Status Completed
Phase Phase 1
Start date April 2013
Completion date May 2013

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 NCT01503450 - Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition Phase 1
Completed NCT01618760 - Bioequivalence Study of Risperidone Tablet 1 mg Under Fed Condition Phase 1
Completed NCT01735383 - Bioequivalence Study of Etodolac Tablet USP 500 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