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Pilot study of food effect on pharmacokinetics of STROMECTOL in scabies patients.

Pilot study of food effect on pharmacokinetics of STROMECTOL in scabies patients. - Pilot study of food effect on pharmacokinetics of STROMECTOL in scabies patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006789
Enrollment
12
Registered
2011-11-29
Start date
2011-06-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

scabies

Interventions

First, 200 ug/kg ivermectin are administerd on fast. A week later, same doses of ivermectin are administerd on food .Observation is continued one week after second administration..

Sponsors

Laboratory of medical safety management, Tokyo University of Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients who were diagnosed with scabies. 2)Patients who needed hospitalization by scabies or other disease. 3)Subjects who understood the requirements of the study and signed the informed consent forms.

Exclusion criteria

Exclusion criteria: 1)Subjects who had in the past or currently have following diseases. ;hepatic diseases ;other diseases which doctor in attendance considered to influence in results of study, or be penalized by administration of ivermectin. 2)Subjects who consumed excessive amounts of coffee or beverage containing caffeine.(over eight cups a day) 3)Drug or alcohol abuser. 4)Illegal drug constant user. 5)Men and women who donated two hundred milliliter of blood within four weeks prior to commencement of this study, or men who donated four hundred milliliter of blood within twelve weeks prior to commencement of this study, and women who donated four hundred milliliter of blood within sixteen weeks prior to commencement of this study. 6)Subjects who participated in another clinical trials with an investigational agent within four weeks prior to commencement of this study. 7)Subjects who had history of hypersensitivity to constituent of STROMECTOL 8)Subjects who are judged as inadequate by doctor in attendance.

Design outcomes

Primary

MeasureTime frame
To analyze ivermectin in blood after fed and fasted administration.

Secondary

MeasureTime frame
To analyze ivermectin in skin, mites after fed and fasted administration.

Countries

Japan

Contacts

Public ContactMasayo Komoda

Tokyo University of Science Faculty of Pharmaceutical Sciences

komo1207@rs.noda.tus.ac.jp04-7121-4134

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026