A study to evaluate the effect of amoxicillin/clavulanate on the pharmacokinetics of valproic acid in healthy adult volunteers

An open-label study to evaluate the effect of amoxicillin/clavulanate on the pharmacokinetics of valproic acid in healthy adult volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001165

Enrollment

Registered

2014-07-15

Start date

2014-05-30

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : At Period I(1d), subjects are administered a valproic acid 500 mg tablet orally. From Period II(6d),subjects are administered an amoxicillin/clavulanate 500/125 mg tablet, 3 times daily, for 7

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Adult male aged 19 to 55 years at screening 2) A body mss index between 19 and 27 kg/m2 at screening 3) A subject who is able to understand the study, and to provide written informed consent voluntarily after being fully informed of the study objectives, procedures and study drug 4) A subejct who is able to participate the whole study period

Exclusion criteria

Exclusion criteria: 1) A subject who has the medical history of or has the clinically significant hepatobiliary, renal, gastrointestinal, respiratory, musculoskeletal, endocrinal, hemato-oncologic, or cardiovascular disease 2) A subject who has systolic blood pressure 1.5 times of upper normal limit 11) A subject who has the glomerular filtration rate (GFR) calculated by plasma creatinine values < lower normal limit 12) A subject who is inadequate for the clinical trial by the investigator’s decision

Design outcomes

Primary

Measure	Time frame
Cmax, AUClast of valproic acid	—

Secondary

Measure	Time frame
tmax, t1/2, AUCinf of valproic acid	—

Countries

Korea, Republic of

Contacts

Public ContactSoo-Yun Lee

Samsung Medical Center

Outcome results