A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects

Infections, Urinary Tract Clinical Trial

Official title:

Comparative Randomized, Single Dose, Two-way Crossover, Open-label Study to Determine the Bioequivalence of Cefadroxil From Duricef 1 gm Film Coated Tablets (Smithkline Beecham Egypt, LLC Affiliated Co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated Tablets (Kahira Pharm &Chem .Ind. Co. for Novartis Pharma ) After a Single Oral Dose Administration of Each to Healthy Adults Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446496
• Other study ID #: 201529
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2015
• Last updated: August 23, 2017
• Start date: March 31, 2014
• Est. completion date: April 8, 2014

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 8, 2014
• Est. primary completion date: April 8, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male or female, age 18 to 55 years, inclusive.

• Body weight within 15 percent of normal range according to the accepted normal values for body mass index (BMI).

• Medical demographics without evidence of clinically significant deviation from normal medical condition.

• Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.

• Subject does not have allergy to the drugs under investigation.

Exclusion Criteria:

• Subjects with known allergy to the products tested.

• Subjects whose values of BMI were outside the accepted normal ranges.

• Female subjects who were pregnant, nursing or taking birth control pills.

• Medical demographics with evidence of clinically significant deviation from normal medical condition.

• Results of laboratory tests which are clinically significant.

• Acute infection within one week preceding first study drug administration.

• History of drug or alcohol abuse.

• Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.

• Subject is on a special diet (for example subject is vegetarian).

• Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.

• Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.

• Subject has a history of severe diseases which have direct impact on the study.

• Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.

• Subject intends to be hospitalized within 6 weeks after first study drug administration.

• Subjects who, through completion of this study, would have donated more than 500 milliliter (mL) of blood in 7 days, or 750 mL of blood in 30 days, 1000 mL in 90 days, 1250 mL in 120 days, 1500 mL in 180 days, 2000 mL in 270 days, 2500 mL of blood in 1 year.

Related Conditions & MeSH terms

• Infections, Urinary Tract
• Urinary Tract Infections

Intervention

Drug:
• Cefadroxil tablets manufactured by GSK
Cefadroxil tablets manufactured by GSK contains 1 mg of Cefadroxil
• Cefadroxil tablets manufactured by NP
Cefadroxil tablets manufactured by NP contains 1 mg of Cefadroxil

Locations

Country	Name	City	State
Egypt	GSK Investigational Site	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Measured Plasma Concentration (Cmax) After a Single Dose	Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.	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.
Primary	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)	Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Area under the plasma concentration-time curve from time zero (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method. Area under the plasma concentration-time curve from time zero (0) to infinity (AUC0-infinity) was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant (Ke), where first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.	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	Time of the Maximum Plasma Concentration (T-max) and Terminal Half- Life (T-half)	Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.	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	Apparent First-order Elimination or Terminal Rate Constant (Ke)	Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.	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.

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