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Clinical study about in vitro - in vivo correlation in supersaturation of poorly soluble basic drug

Clinical study about in vitro - in vivo correlation in supersaturation of poorly soluble basic drug - Clinical study about IVIVC in poorly soluble basic drug

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033055
Enrollment
18
Registered
2018-06-19
Start date
2018-06-25
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

Healthy male

Interventions

Single oral administration of albendazole and acetaminophen Single oral administration of albendazole, acetaminophen and diluted hydrochloric acid Single oral administration of albendazole, acetaminop

Sponsors

Ritsumeikan University
Lead Sponsor
Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co., Ltd., Towa Pharmaceutical co., ltd., JAPAN TOBACCO INC., Asahi Kasei Pharma Corporation., SHIONOGI &amp
Collaborator
CO., LTD., ONO PHARMACEUTICAL CO., LTD., DAIICHI SANKYO RD NOVARE CO., LTD., DAIICHI SANKYO CO., LTD. Sawai Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd. , Japan Machinery Company
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese male subjects who provide signed written informed consent. 2. Subjects between 20 and 40 (inclusive) year of age at the time of consent. 3. Subjects with BMI <=18.5 and >25.0 at the time of screening. 4. Subjects judged as adequate for this study by study physician.

Exclusion criteria

Exclusion criteria: 1. Subjects who had gastrointestinal resection and vagotomy 2. Subjects with present illness which requires treatment. 3. Subjects with past medical history which was considered not adequate for this study. 4. Subjects with past history of drug allergy. 5. Subjects who took prescribed medicine and/or OTC drug 1 week prior to admission of period 1. 6. Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200 mL within 4 weeks, and/or blood component within 2 weeks prior to admission of period 1. 7. Subjects who participated in a clinical trial and was administered study drug within 16 weeks prior to admission of period 1. 8. Subjects with history of alcohol and/or drug abuse. 9. Subjects who were judged not appropriate for this study by study physician.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics of albendazole and albendazole sulfoxide—

Countries

Japan

Contacts

Public ContactTakuya Fujita

Ritsumeikan University College of Pharmaceutical Sciences

fujita-t@ph.ritsumei.ac.jp077-561-5974

Outcome results

None listed

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