A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Meropenem In Healthy Volunteers(Meropenem Intravenous Injection) After Intravenous Infusion

Yung Shin Pharm. Ind. Co., Ltd.0 sites14 target enrollmentSeptember 2014

ConditionsHealthy

InterventionsMeropem Mepem

DrugsMeropem Mepem

Overview

Phase: Phase 4
Intervention: Meropem
Conditions: Healthy
Sponsor: Yung Shin Pharm. Ind. Co., Ltd.
Enrollment: 14
Primary Endpoint: Adverse events and incidences
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

December 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Yung Shin Pharm. Ind. Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

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.