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Fed Bioequivalence Study of CBZ Formulations

NCT02132897 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-06-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Center for Clinical Pharmacology Research Bdbeq S.A.

    lead OTHER

Principal Investigators

  • Francisco E. Estevez-Carrizo, M.D. · Center for Clinical Pharmacology Research Bdbeq S.A.

  • Francisco T. Estevez-Parrillo, M.D. · Center for Clinical Pharmacology Research Bdbeq S.A.

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Uruguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02132897 on ClinicalTrials.gov