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Vilon

KE, L-Lys-L-Glu, lysylglutamic acid

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Studies 40
Trials 100
Completed PHASE1 INTERVENTIONAL NCT02132897

Fed Bioequivalence Study of CBZ Formulations

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: AUC0-240
TimeFrame: 10 days
Description: Area Under the CBZ Concentration vs. time curve from sample time point 0 hour to sample time point 240 hour.
Measure: AUC0-inf
TimeFrame: 0 to 240 hours
Description: Area Under the CBZ Concentrations vs, time curve from sample time point 0 hour to sample time point 240 hours plus extrapolation to infinity of the terminal concentration slope.
Measure: Cmax
TimeFrame: 12 to 48 hours
Description: The maximum concentration in the CBZ concentrations vs. time curves for each subject and each formulation.

Trial Information

NCT ID

NCT02132897

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Center for Clinical Pharmacology Research Bdbeq S.A.

Last Updated

December 15, 2025