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

Sponsor
Chonbuk National University (Other)
Overall Status
Completed
CT.gov ID
NCT01073059
Collaborator
(none)
10
Enrollment
1
Location
1
Arm

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Valproic acid and Ertapenem
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Open-label, Two-period, One Sequence, Multiple Dose, Crossover Study, A Study to Investigate Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Healthy Male Subjects
Study Start Date :
Aug 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Valproic acid

Drug: Valproic acid and Ertapenem

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. 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]

  4. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chonbuk National University Hospital Jeonju Jeollabuk-do Korea, Republic of 561-712

Sponsors and Collaborators

  • Chonbuk National University

Investigators

  • Principal Investigator: Chang-Seop Lee, MD/Prof., Chonbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01073059
Other Study ID Numbers:
  • CUH_2009_VPA
First Posted:
Feb 23, 2010
Last Update Posted:
Dec 8, 2010
Last Verified:
Feb 1, 2010
Keywords provided by , ,
valproic acid
ertapenem
Additional relevant MeSH terms:
Ertapenem
Valproic Acid

Study Results

No Results Posted as of Dec 8, 2010