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Bioequivalence Study of Cyclosporine 100mg Capsule Under Fasting Condition

2014-08-27 03:15:29 | BioPortfolio

Summary

To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis Pharmaceuticals Corporation, New Jersey, in 36 healthy adult male subjects under fasting condition.

Description

Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to dose administration and for at least 4 hours post dose. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post dose in each period. A total of 24 blood samples will be withdrawn for pharmacokinetic profiling. The whole blood concentrations of Cyclosporine will be measured by a validated LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy Volunteers

Intervention

Cyclosporine Capsules USP (Modified) 100 mg

Location

Accutest Research Laboratories (I) Pvt Ltd.
Ahmedabad
Gujrat
India
380015

Status

Completed

Source

Panacea Biotec Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:29-0400

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