A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants

Healthy Volunteers Clinical Trial

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 125 mg/5 ml of Cephalexin (Keflex® Pediatrico Made in Mexico by Eli Lilly y Compañía de México, S.A. de C.V. vs. Keflex® Pediatrico 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123472
• Other study ID #: 15315
• Secondary ID: A3Q-ME-AFBR
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2014
• Last updated: June 19, 2015
• Start date: May 2014
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Cephalexin
Administered Orally

Locations

Country	Name	City	State
Mexico	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-8)] 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	No
Secondary	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	No
Secondary	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	No