Clinical trial NCT02123446: A Study of Cephalexin Capsules in Healthy Participants
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 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
First posted: 2014-04-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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 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).

Primary outcomes:
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve of Cephalexin From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose
timeFrame: 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 outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin
timeFrame: 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
measure: Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum
timeFrame: 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
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: