Healthy Volunteers
Conditions
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.
Interventions
DRUGCephalexin
Administered orally
Sponsors
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose | 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
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin | 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 |
| Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum | 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 |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion). | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout Period (1 Day) | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 30.9 Years STANDARD_DEVIATION 9.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Mexico | 28 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 2 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
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
Population: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cephalexin (Reference) | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose | 29.539 Hours*microgram per milliliter(h*μg/mL) | Geometric Coefficient of Variation 22.919 |
| Cephalexin (Test) | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose | 35.857 Hours*microgram per milliliter(h*μg/mL) | Geometric Coefficient of Variation 14.452 |
Secondary
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
Population: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cephalexin (Reference) | Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin | 10.378 μg/mL | Geometric Coefficient of Variation 25.616 |
| Cephalexin (Test) | Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin | 12.610 μg/mL | Geometric Coefficient of Variation 23.867 |
Secondary
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
Population: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Cephalexin (Reference) | Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum | 1.500 Hours | Standard Deviation 0.881 |
| Cephalexin (Test) | Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum | 1.500 Hours | Standard Deviation 0.758 |