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A Study of Cephalexin Suspension in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02123459
Recruitment Status : Completed
First Posted : April 25, 2014
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Cephalexin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 250 mg/5 ml of Cephalexin (Keflex® Liquido Made in Mexico by Eli Lilly y Compañía de México, S.A. de C.V. vs. Keflex® Liquido Made by Antibioticos do Brasil Ltda for Eli Lilly y Compañía de México, S.A. de C.V.) in Fasting Healthy Volunteers
Study Start Date : May 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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 Name: Keflex®

Active Comparator: Cephalexin (Test)
Cephalexin manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
Drug: Cephalexin
Administered orally
Other Name: Keflex®




Primary Outcome Measures :
  1. Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose [ Time Frame: 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 :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin [ Time Frame: 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 ]
  2. Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum [ Time Frame: 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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123459


Locations
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, Mexico, 14610
Sponsors and Collaborators
Eli Lilly and Company
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Investigators
Study Director: 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) Eli Lilly and Company

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02123459     History of Changes
Other Study ID Numbers: 15314
A3Q-ME-AFBQ ( Other Identifier: Eli Lilly and Company )
First Posted: April 25, 2014    Key Record Dates
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Cephalexin
Anti-Bacterial Agents
Anti-Infective Agents