FED Clinical Trial
Official title:
An Open-label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablet of Dr. Reddy's Laboratories Limited Comparing With That of Cellcept 500 mg Tablet of Roche Laboratories in Healthy, Adult,Human, Male Subjects Under Non-fasting Conditions.
To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under non-fasting conditions and to assess the bioequivalence.
This was an open-label, balanced, randomized, two-treatment, two-period, two-sequence,single dose, crossover bioequivalence study in healthy, adult, human, male subjects under non-fasting conditions.92 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One tablet containing mycophenolate mofetil 500 mg was administered orally with 240 mL water in sitting posture, after 30 minutes of serving of the high fat and high calorie breakfast in each period. This activity was followed by a mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the first three hours after dosing. ;
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 |
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 | |
| Completed |
NCT01884909 -
Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fed Conditions
|
Phase 1 |