Infections, Urinary TractPhase 4NCT02446496

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

A Phase 4 study testing Cefadroxil tablets manufactured by GSK and Cefadroxil tablets manufactured by NP in people with Infections, Urinary Tract, run by GlaxoSmithKline at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Urinary Tract
What is being tested?: Cefadroxil tablets manufactured by GSK and Cefadroxil tablets manufactured by NP
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteEgypt
Study dates: 31 Mar 2014to 8 Apr 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

GSK Investigational Site
Cairo

Other trials in Egypt

About this study

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

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.

Conditions: Infections, Urinary Tract
Being tested: Cefadroxil tablets manufactured by GSK, Cefadroxil tablets manufactured by NP
Keywords: Bioequivalence, film coated tablets, cefadroxil
Medical subject headings: Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cefadroxil tablets manufactured by GSKDrug
Cefadroxil tablets manufactured by GSK contains 1 mg of Cefadroxil
Cefadroxil tablets manufactured by NPDrug
Cefadroxil tablets manufactured by NP contains 1 mg of Cefadroxil

Study groups in NCT02446496
Study group	Role	What they receive
Group A	Experimental	Subjects will receive a single oral dose of cefadroxil tablet manufactured by GSK under fasting condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of cefadroxil tablet manufactured by NP under fasting condition in treatment period 2 Receives: Drug: Cefadroxil tablets manufactured by GSK; Drug: Cefadroxil tablets manufactured by NP
Group B	Experimental	Subjects will receive a single oral dose of cefadroxil tablet manufactured by NP under fasting condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of cefadroxil tablet manufactured by GSK under fasting condition in treatment period 2 Receives: Drug: Cefadroxil tablets manufactured by GSK; Drug: Cefadroxil tablets manufactured by NP

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: 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 (2)

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.
Measured: 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)
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 20148 Apr 2014

First posted18 May 2015 (estimated)
Study start31 Mar 2014
Primary completion8 Apr 2014
Study completion8 Apr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Infections, Urinary TractStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02446496
Sponsor's protocol ID: 201529
Status last verified: Aug 2017
First submitted: 14 May 2015
Last updated: 21 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02446496
Acronym / sponsor ID: 201529
Conditions: Infections, Urinary Tract
Keywords: Bioequivalence, film coated tablets, cefadroxil
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 31 Mar 2014 (actual)
Primary completion: 8 Apr 2014 (actual)
Study completion: 8 Apr 2014 (actual)
First posted: 18 May 2015 (estimated)
Results: Posted 25 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: Cefadroxil tablets manufactured by GSK, Drug: Cefadroxil tablets manufactured by NPSubjects will receive a single oral dose of cefadroxil tablet manufactured by GSK under fasting condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of cefadroxil tablet manufactured by NP under fasting condition in treatment period 2
Group B	Experimental	Drug: Cefadroxil tablets manufactured by GSK, Drug: Cefadroxil tablets manufactured by NPSubjects will receive a single oral dose of cefadroxil tablet manufactured by NP under fasting condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of cefadroxil tablet manufactured by GSK under fasting condition in treatment period 2

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cefadroxil tablets manufactured by GSKCefadroxil tablets manufactured by GSK contains 1 mg of Cefadroxil	Drug	Group A, Group B
Cefadroxil tablets manufactured by NPCefadroxil tablets manufactured by NP contains 1 mg of Cefadroxil	Drug	Group A, Group B

Primary outcome

Maximal Measured Plasma Concentration (Cmax) After a Single Dose
Time frame: 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.
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.
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)
Time frame: 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.
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.

2 secondary outcomes

Time of the Maximum Plasma Concentration (T-max) and Terminal Half- Life (T-half)
Time frame: 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)
Time frame: 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.

Results and safety

Results posted to the registry on 25 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm	24	24

Primary outcome: Maximal Measured Plasma Concentration (Cmax) After a Single Dose

Time frame: 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.. Geometric mean (Geometric Coefficient of Variation). Unit: Microgram per milliliter

Measure	Treatment A-cefadroxil 1 gm n = 24	Treatment B-cefadroxil 1 gm n = 24
Value	28.18 (8.12)	29.20 (8.80)

Treatment A-cefadroxil 1 gm vs Treatment B-cefadroxil 1 gm: Point estimate percent: 95.91 (90% CI 85.67 to 107.37)

Population analysed: All subject population: who were crossed over and completed the balance design, were included in the calculation. All participants were present at the time of measurement.

Primary outcome: 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)

Measure	Treatment A-cefadroxil 1 gm n = 24	Treatment B-cefadroxil 1 gm n = 24
AUC(0-t)	106.55 (28.64)	102.21 (26.06)
AUC(0-infinity)	111.71 (30.15)	106.08 (26.40)

Treatment A-cefadroxil 1 gm vs Treatment B-cefadroxil 1 gm: Point estimate percent: 102.31 (90% CI 90.46 to 115.70)
Treatment A-cefadroxil 1 gm vs Treatment B-cefadroxil 1 gm: Point estimate percent: 103.13 (90% CI 91.19 to 116.62)

Population analysed: All subject population. All participants were present at the time of measurement.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 11 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A-cefadroxil 1 gm	0 of 24 (0%)	0 of 24 (0%)	Not reported
Treatment B-cefadroxil 1 gm	0 of 24 (0%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cefadroxil tablets manufactured by GSK and Cefadroxil tablets manufactured by NP in people with Infections, Urinary Tract, run by GlaxoSmithKline at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Measured Plasma Concentration (Cmax) After a Single Dose (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.