Fed Clinical Trial
Official title:
A Randomized, Open Label, Two-Treatment, Two-Period, Two-Sequence, Crossover, Single Dose, Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg With Seroquel® 25 mg in Normal, Healthy, Adult, Human Subjects, Under Fed Condition
This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, 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 normal, healthy, adult, human subjects.
Objective of this pivotal study was to assess the bioequivalence between Test Product:
Quetiapine Fumarate Tablets 25 mg of M/s Ipca Laboratories Limited, India and the
corresponding Reference Product: Seroquel® (Quetiapine fumarate) Tablets 25 mg of M/s
AstraZeneca Pharmaceuticals LP, USA, under fed condition in normal, healthy, adult, human
subjects in a randomized crossover study.
The study was conducted with 54 healthy adult subjects. In each study period, a single 25 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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
NCT01283932 -
Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fed Condition
|
Phase 1 | |
| Completed |
NCT01372306 -
Galantamine Bioequivalence Study of Dr. Reddy's 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 |