Bioequivalence of Two Formulations of Meropenem Intravenous Injection
Bioequivalence of Two Formulations of Meropenem Intravenous Injection
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two
 formulations of meropenem (meropenem intravenous injection 0.5 g) after intravenous infusion
 in healthy volunteers.
Inclusion Criteria:

 -  Healthy adult male or female subjects between 20-45 years of age.

 -  Body weight within 80-120% of ideal body weight and higher than or equal to 50 kg for
 male subjects and 45 kg for female subjects.

 -  Ideal body weight (kg) = [height (cm) - 80] × 0.7 for male subjects

 -  Ideal body weight (kg) = [height (cm) - 70] × 0.6 for female subjects

 -  Acceptable medical history and physical examination including:

 no particular clinically significant abnormality in X-ray and ECG results within six months
 prior to study. no particular clinical significance in general disease history within two
 months prior to study.

 -  Acceptable vital signs (within normal limits or considered by the investigator or
 physician to be of no clinical significance) at screening, which includes pulse rate,
 blood pressure and body temperature.

 -  Acceptable clinical chemistry determinations (within normal limits or considered by
 the investigator or physician to be of no clinical significance) within two months
 prior to study, which includes AST (SGOT), ALT (SGPT), γ-GT, alkaline phosphatase,
 total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol and
 triglyceride (TG).

 -  Acceptable hematology (within normal range or considered by the investigator or
 physician to be of no clinical significance) within two months prior to study, which
 includes hemoglobin, hematocrit, red blood cell count, white blood cell count with
 differentials and platelets.

 -  Acceptable urinalysis (within normal limits or considered by the investigator or
 physician to be of no clinical significance) within two months prior to study, which
 includes pH, blood, glucose, ketones, bilirubin and protein.

 -  Female subjects of childbearing potential practicing an acceptable method of birth
 control from at least seven days prior to study until the end of study as judged by
 the investigator(s) or surgically sterile (bilateral tubal ligation, bilateral
 oophorectomy or hysterectomy performed on the subject).

 -  Have signed the written informed consent to participate in the study.

 Exclusion Criteria:

 -  A clinically significant disorder involving the cardiovascular, respiratory, hepatic,
 renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s)
 or psychiatric disease (as determined by the clinical investigator).

 -  A clinically significant illness or surgery within four weeks prior to study (as
 determined by the investigator).

 -  History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder
 disease, pancreas disorder over last two years or history of gastrointestinal tract
 surgery over last five years.

 -  History of kidney disease or urination problem over last two years deemed by the
 investigator to be clinically significant.

 -  Known or suspected history of drug abuse within lifetime as judged by the
 investigator.

 -  History of alcohol addiction or abuse within last five years as judged by the
 investigator.

 -  Have a personal history or family history of drug allergy.

 -  Subjects demonstrating a positive meropenem skin test screen prior to the study.

 -  Evidence of chronic or acute infectious diseases.

 -  Female subjects demonstrating a positive urine pregnancy screen prior to study.

 -  Female subjects who are currently breastfeeding.

 -  Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks
 prior to study. Examples of inducers include: piperidines, carbamazepine,
 dexamethasone and rifampin. Examples of inhibitors include: cimetidine,
 diphenhydramine, fluvastatin, methadone and ranitidine.

 -  Taking any prescription medications within four weeks or any nonprescription
 medications (excluding flu vaccination) within two weeks prior to study.

 -  Use of any investigational drug within four weeks prior to study.

 -  Donating more than 250 mL of blood within two months prior to study or donating plasma
 (e.g. plasmapheresis) within two weeks prior to study.

 -  Any other medical reason as determined by the clinical investigator.