Healthy Volunteers | A Study of Cephalexin in Healthy Participants
Healthy Volunteers research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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 and 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).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Cephalexin (Test)Cephalexin manufactured in Italy by Facta administered once orally in one of two study periods.
Cephalexin (Reference)Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
Start Date: April 2014
Completed Date: May 2014
Phase: Phase 1
Primary Outcome: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose
Secondary Outcome: Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum
Study sponsors, principal investigator, and references
Principal Investigator: 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)
Lead Sponsor: Eli Lilly and Company
Collaborator: Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.