NCT02132897

Fed Bioequivalence Study of CBZ Formulations

Fed Bioequivalence Study of Carbamazepine Controlled Release Formulations in Healthy Male Uruguayan Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Center for Clinical Pharmacology Research Bdbeq S.A. · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with time due to metabolism autoinduction. The primary objective of this study is to estimate the bioequivalence of the new brand generic product (Auration(R) CR) 400 mg manufactured in Uruguay vs. the innovative product (Tegretol(R) CR) 400 mg manufactured in Brasil, under fed conditions. The secondary objective will be evaluation of safety issues. The study design will be randomized two sequences, two periods and crossover. For a power of not less than 80% sample size was estimated to be 20 healthy male subjects. Products will be administered with food (high calories/high fat breakfast) after an overnight fast. Time vs. concentration curves will be built for each subject and formulation and Area Under Curve (AUC0240) will be estimated using the trapezoid rule, the AUC 0-inf. (from time 0 to infinity) will be estimated using the formula Cz/Ke, Cmax will be taken from the individual curves. This parameters will be statistically processed with the WinNonlin 6.3 Pharmacokinetics/Statistic software in order to prove bioequivalence between the study products.

Conditions

• Bio-equivalence Study
• Fed Conditions

Interventions

Type	Name	Description
DRUG	Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose	Carbamazepine CR Tablets 400 milligrams is given orally with 250 mL of water at room temperature.
DRUG	Tegretol CR 400 Single Dose-Auration CR 400 Single Dose	Auration CR 400 milligrams Single Dose is given orally with 250 mL of water at room temperature.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-05-07
• Last updated: 2014-06-17

Locations

1 site across 1 country: Uruguay