A Study of Cephalexin Capsules in Healthy Participants

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).