Healthy VolunteersPhase 1NCT02123459

A Study of Cephalexin Suspension in Healthy Participants

A Phase 1 study testing Cephalexin in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Mexico.

Completed

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

Trial summary

The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Cephalexin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteMexico
Study dates: May 2014to May 2014
Phase: Phase 1
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participation will be voluntary.
The body mass index of participants should be between 18-27.
Participants should have a good health status.
Limits of variation allowed within normal values at screening will be: blood pressure (seated) up to 139 millimeters of mercury (mm Hg), for systolic, and up to 89 mm Hg for diastolic; heart rate between 60 and 100 beats per minute, and respiratory rate between 14 and 20 breaths per minute.
Hepatitis B and C and human immunodeficiency virus (HIV) negative.
Drug abuse or alcohol detection test approximately 12 hours before administering the study medication.
Serum pregnancy test (beta human chorionic gonadotropin) at screening and urine pregnancy test approximately 12 hours before administering the study medication.

Who cannot join

Participants with any clinically significant abnormality in their vital sign constants recorded at screening.
Sponsor´s and/or site employees.
Abnormal 12 lead electrocardiogram (ECG) that in the opinion of the investigator places the participant at an unacceptable risk for study participation, Bazett corrected QR interval (QTcB) > 470 millisecond (msec) for women and > 450 msec for men.
Participants with history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal diseases, including constipation, neurological, endocrine, hematopoietic diseases, or any type of anemia, asthma, mental disease, or other organic abnormalities.
Participants with a creatinine clearance < 80 mL/min based on the Cockcroft-Gault equation.
Participants requiring any medication during the study, apart from the medication which is being studied.

Show all 19Show fewer

Participants with history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer.
Participants who have been exposed to medications known as hepatic enzyme inducers or inhibitors or who have been taking potentially toxic medications within the 30 days prior.
Participants who have received any medication, including vitamins (with or without medical prescription) or herbal-based remedies 30 days (or 7 half-lives) prior to the beginning of the study.
Participants who have been hospitalized for any condition within six months to the beginning of the study.
Participants who have received investigational drugs within the 60 days prior to the study.
Participants allergic to any medication, food, or substance.
Participants who require therapy with nephrotoxic drugs.
Participants who have donated 450 mL of blood or more within the 60 days prior to the beginning of the study.
Participants with history of drug and alcohol abuse.
Participants with special diet requirement for any cause.
Participants with positive to pregnancy test or are breastfeeding.
Participants on hormonal treatment by any route.
Participants who have not been recorded in the page of the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS).

Trial locations and contacts

1 site in 1 country.

Mexico1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City, 14610

Other trials in Mexico

About this study

Official title: A Randomized, Open-label, Two-period, Two-treatment, Two-sequence, Crossover Study to Evaluate the Bioequivalence of Single Doses of Two Oral Preparations in Suspension With 250 mg/5 ml of Cephalexin (Keflex® Liquido Made in Mexico by Eli Lilly y Compañía de México, S.A. de C.V. vs. Keflex® Liquido Made by Antibioticos do Brasil Ltda for Eli Lilly y Compañía de México, S.A. de C.V.) in Fasting Healthy Volunteers

Conditions: Healthy Volunteers
Being tested: Cephalexin

What participants receive

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

CephalexinDrug
Also called Keflex®
Administered orally

Study groups in NCT02123459
Study group	Role	What they receive
Cephalexin (Reference)	Experimental	Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods Receives: Drug: Cephalexin
Cephalexin (Test)	Active comparator	Cephalexin manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods Receives: Drug: Cephalexin

What is being measured

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

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose
Measured: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period

Secondary outcomes (2)

Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin
Measured: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period
Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum
Measured: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period

Timeline

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

May 2014May 2014

First posted25 Apr 2014 (estimated)
Study startMay 2014
Primary completionMay 2014
Study completionMay 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 Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02123459
Sponsor's protocol ID: 15314
Other IDs: A3Q-ME-AFBQ
Status last verified: May 2015
First submitted: 23 Apr 2014
Last updated: 27 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Two-period, Two-treatment, Two-sequence, Crossover Study to Evaluate the Bioequivalence of Single Doses of Two Oral Preparations in Suspension With 250 mg/5 ml of Cephalexin (Keflex® Liquido Made in Mexico by Eli Lilly y Compañía de México, S.A. de C.V. vs. Keflex® Liquido Made by Antibioticos do Brasil Ltda for Eli Lilly y Compañía de México, S.A. de C.V.) in Fasting Healthy Volunteers
ClinicalTrials.gov ID: NCT02123459
Acronym / sponsor ID: 15314
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Study start: May 2014
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 25 Apr 2014 (estimated)
Results: Posted 27 May 2015

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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cephalexin (Reference)	Experimental	Drug: CephalexinCephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
Cephalexin (Test)	Active comparator	Drug: CephalexinCephalexin manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Participation will be voluntary.
The body mass index of participants should be between 18-27.
Participants should have a good health status.
Limits of variation allowed within normal values at screening will be: blood pressure (seated) up to 139 millimeters of mercury (mm Hg), for systolic, and up to 89 mm Hg for diastolic; heart rate between 60 and 100 beats per minute, and respiratory rate between 14 and 20 breaths per minute.
Hepatitis B and C and human immunodeficiency virus (HIV) negative.

Key exclusion criteria (19 listed)

Participants with any clinically significant abnormality in their vital sign constants recorded at screening.
Sponsor´s and/or site employees.
Abnormal 12 lead electrocardiogram (ECG) that in the opinion of the investigator places the participant at an unacceptable risk for study participation, Bazett corrected QR interval (QTcB) > 470 millisecond (msec) for women and > 450 msec for men.
Participants with history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal diseases, including constipation, neurological, endocrine, hematopoietic diseases, or any type of anemia, asthma, mental disease, or other organic abnormalities.
Participants with a creatinine clearance < 80 mL/min based on the Cockcroft-Gault equation.

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
CephalexinAlso: Keflex®Administered orally	Drug	Cephalexin (Reference), Cephalexin (Test)

Primary outcome

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period

2 secondary outcomes

Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period
Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period

Results and safety

Results posted to the registry on 27 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cephalexin Dosing Sequence AB	14	14
Cephalexin Dosing Sequence BA	14	14

Primary outcome: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose

Time frame: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period. Geometric mean (Geometric Coefficient of Variation). Unit: Hours*microgram per milliliter(h*μg/mL)

Measure	Cephalexin (Reference) n = 27	Cephalexin (Test) n = 27
Value	29.539 (22.919)	35.857 (14.452)

Population analysed: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cephalexin (Reference)	0 of 28 (0%)	0 of 28 (0%)	Not reported
Cephalexin (Test)	0 of 28 (0%)	2 of 28 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cephalexin in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Mexico.

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 7 inclusion and 19 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 27 May 2015. 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 Mexico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 27 May 2015). 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?

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose (time frame: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period). 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 NCT02123459.

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 27 May 2015.