Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

• This trial is conducted to assess pharmacokinetic characteristics of valproic acid when valproic acid single treatment and valproic acid & ertapenem combination treatment

• This trial is performed to evaluate safety of the combination treatment compare with single treatment

• The investigators carry this trial out to study mechanism of combination treatment

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chonbuk National University
• Treatments: Ertapenem; Valproic Acid

Criteria

Inclusion Criteria:

• Subjects who are healthy volunteers, men 19~50 years

• Subjects who have a weight more then 50kg and a condition ± 20% range of ideal weight

Exclusion Criteria:

• Subjects with evidence of clinically significant hepatic, pancreatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric or cardiovascular disease

• Subjects who have a GI disease (crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery

• Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure≤ 100 mmHg or diastolic blood pressure≤ 65 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement

• Subjects with known allergy, hypersensitivity (anaphylaxis-type reaction; especially penicillin antibiotics)

• Subjects with a history of drug abuse

• Subjects who received certain medication (include oriental medicine) within the past 3 weeks or certain OTC-drug within 1 week

• Subjects who participated in other clinical investigation within 2months prior to first administration Subjects who did whole blood donation (within 2months) or apheresis (within 1months) prior to first administration

• Subjects who are chronic drinkers