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

Chonbuk National University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Valproic acid and Ertapenem

Study type: Interventional

Funder types: Other

Identifiers

NCT01073059

CUH_2009_VPA

Details and patient eligibility

About

• 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

Enrollment: 10 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Valproic acid

Experimental group

Treatment:

Drug: Valproic acid and Ertapenem