A Study of Cephalexin Liquid in Healthy Participants

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 cv. 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

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. The study is expected to last about 2 days for each participant, not including screening or follow-up.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Cephalexin

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14610
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.
• Negative drug abuse or alcohol detection test approximately 12 hours before administering the study medication.
• Negative serum pregnancy test (beta human chorionic gonadotropin) at screening and urine pregnancy test approximately 12 hours before administering the study medication.

Exclusion Criteria:

• Participants with any clinically significant abnormality in their vital sign constants recorded at screening.
• Sponsor 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.
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cephalexin (Reference); Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.	Drug: Cephalexin; Administered orally; Other Names: Keflex®; LY066873
Active Comparator: Cephalexin (Test); Cephalexin manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.	Drug: Cephalexin; Administered orally; Other Names: Keflex®; LY066873

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Cephalexin Following a Single Dose	Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period
Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin Following a Single Dose	Predose,0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 7, 2015

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: September 5, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cephalexin
• Other Study ID Numbers: 16062; A3Q-ME-AFBS (Other Identifier: Eli Lilly and Company)