A Study of Cephalexin Capsules 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 Capsules With 250 mg of Cephalexin (Keflex® Made in Mexico by Eli Lilly y Compañía de México, S.A. de C.V. vs. Keflex® Made in Italy by Facta Farmaceutici S.p.A. 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 in capsules 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 Volunteers
• 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: Yes
• 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.
• 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.

Exclusion Criteria:

• 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 milliliter per minute (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
• Masking: NONE

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®
ACTIVE_COMPARATOR: Cephalexin (Test); Cephalexin manufactured in Italy by Facta administered once orally in one of two study periods.	Drug: Cephalexin; Administered orally.; Other Names: Keflex®

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Time Frame
Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum	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: Maximum Concentration (Cmax) of Cephalexin	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

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: April 1, 2014
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (ESTIMATE): April 25, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 15, 2015
• Last Update Submitted That Met QC Criteria: June 19, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cephalexin
• Other Study ID Numbers: 15313; A3Q-ME-AFBP (OTHER: Eli Lilly and Company)