A Study of Cephalexin Capsules in Healthy Participants
Condition: Healthy Volunteers
Intervention: Cephalexin
Intervention description: Administered orally.
Intervention MeSH terms: Cephalexin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

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).