Overview

A Study of Cephalexin Suspension in Healthy Participants

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Eli Lilly and Company
Collaborator:
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Treatments:
Cephalexin
Criteria
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).