Completed

Study Description:

This is an open-label, randomized, single dose, two-sequence two-period crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of cefadroxil from DURICEF™ film coated tablets manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and cefadroxil from BIODROXIL™ film coated tablets manufactured by Kahira Pharm &Chem .Ind. Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a trademark of Sandoz.

GSK Study ID:

201529


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT02446496


Has Results Available Below
EudraCT Number:

Not Available


Study Overview

Medical Conditions

Immune, Inflammatory & Infections - Other

Product

cefadroxil

Collaborators

N/A


Date

March 2014 to April 2014

Type

Interventional

Phase

4


Gender

All

Age

18 years - 55 years

Accepts Healthy Volunteers

Yes


This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

Egypt, Cairo Completed

Study Design

  • Primary Purpose: Other
  • Allocation: Randomized
  • Study Design: Crossover Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Maximal measured plasma concentration (Cmax) after a single dose
    Timeframe: Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.

  • Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) and area under the plasma concentration-time curve from time zero to infinity (AUC0-infinity)
    Timeframe: Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.

Secondary Outcomes:

  • Time of the maximum plasma concentration (T-max) and Terminal half- life (T-half)
    Timeframe: Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.

  • Apparent first-order elimination or terminal rate constant (Ke)
    Timeframe: Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.

Arms:
  • 2

Interventions:

  • Drug: Cefadroxil tablets manufactured by GSK
  • Drug: Cefadroxil tablets manufactured by NP

Keyword:

  • Bioequivalence, film coated tablets, cefadroxil
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 24