Bioequivalence of Two Formulations of Meropenem Intravenous Injection

NCT02344563 | Completed Phase 4

• 1 other identifier: YSP-RBH3012-03
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

• Adverse events and incidences

  predose to 6 hours post dose

Secondary Outcomes (1)

• Pharmacokinetic parameters

  pre dose to 6 hours post dose

Study Arms (2)

Meropem

EXPERIMENTAL

0.5g/vial,one vial

Drug: Meropem; Drug: Mepem

Mepem

ACTIVE COMPARATOR

0.25g/vial ,two vials

Drug: Meropem; Drug: Mepem

Interventions

Meropem DRUG

Mepem; Meropem

Mepem DRUG

Mepem; Meropem

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yung Shin Pharm. Ind. Co., Ltd.: lead

Study Officials

• Zhi-Yuan Shi, M.D.

  zyshi@vghtc.gov.tw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 26, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 26, 2015

Record last verified: 2015-01