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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Valproic acid and Ertapenem

• Registration Number: NCT01073059
• Lead Sponsor: Chonbuk National University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Status Verified: 2010-02
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Valproic acid	Valproic acid and Ertapenem	-

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid single treatment	serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol
Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid and Ertapenem combination treatment	serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol
Area Under the Concentration Versus Time Curve in Valproic acid single treatment	serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol
Area Under the Concentration Versus Time Curve in Valproic acid and Ertapenem combination treatment	serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of