Fed Bioequivalence Study of CBZ Formulations
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|ClinicalTrials.gov Identifier: NCT02132897|
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : June 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Bio-equivalence Study Fed Conditions||Drug: Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose Drug: Tegretol CR 400 Single Dose-Auration CR 400 Single Dose||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Fed Bioequivalence Study of Carbamazepine Controlled Release Formulations in Healthy Male Uruguayan Subjects|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
TR (Test - Reference)
Sequence : Auration CR 400 Single Dose/Tegretol CR 400 Single Dose
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.
RT (Reference - Test)
Sequence: Tegretol CR 400 Single Dose/Auration CR 400 Single Dose
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.
- AUC0-240 [ Time Frame: 10 days ]Area Under the CBZ Concentration vs. time curve from sample time point 0 hour to sample time point 240 hour.
- AUC0-inf [ Time Frame: 0 to 240 hours ]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.
- Cmax [ Time Frame: 12 to 48 hours ]The maximum concentration in the CBZ concentrations vs. time curves for each subject and each formulation.
- AE [ Time Frame: 31 days ]Recording of all adverse events (AE) occurring during the study: expected, unexpected and serious (SAE) from tree different sources. The AEs may be clinical occurrences, abnormal labs or ECG alterations.
- Tmax [ Time Frame: 12 to 48 hours ]Time from 0 concentration sample point to the Cmax sample point.
- Ke [ Time Frame: From 48 to 240 hours ]The constant rate of elimination (Ke) is the slope of the terminal phase of the CBZ concentration vs. time curve.
- T1/2e [ Time Frame: 48 to 240 hours ]It is the time that CBZ concentration, in the elimination (terminal) phase, fall off by half.
- Vital signs [ Time Frame: 20 days ]Measuring of blood pressure, heart rate, body temperature and ventilation rate.
- Admission and discharge screening [ Time Frame: 21 days ]Laboratory analysis and ECG performed prior to admission to the clinic and prior to discharge from the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132897
|Center for Clinical Pharmacology Research Bdbeq S.A. Italian Hospital|
|Montevideo, Uruguay, 11800|
|Study Director:||Francisco E. Estevez-Carrizo, M.D.||Center for Clinical Pharmacology Research Bdbeq S.A.|
|Principal Investigator:||Francisco T. Estevez-Parrillo, M.D.||Center for Clinical Pharmacology Research Bdbeq S.A.|