Exploratory pharmacokinetic study of yokukansan (TJ-54) in healthy volunteers.

Phase 1

• Conditions: Healthy volunteers

• Registration Number: JPRN-jRCT1080221410
• Lead Sponsor: Tsumura & Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1)Subject body mass index (BMI) is between 18.5 and 25 kg/m2
2)Willing and able to provide written, signed informed consent

Exclusion Criteria

1) Subjects with a history of allergic reactions to drugs (including Kampo medicines) and food(s).
2) Female subjects who are pregnant, breastfeeding or planning to become pregnant.
3) Subjects who have participated in another clinical trial within the past 4 months.
4) Subjects who have had their blood drawn or donated > 400mL of blood within 3 months prior to study drug administration.
5) Subject with history of significant hepatic, cardiovascular or hematological disease.
6) Subjects with hepatic steatosis.
7) Current physical dependence and habitual use of alcohol and/or tobacco products.
8) Long-term use of medications (e.g., antipsychotic, antifungal, antihypertensive, Kampo medicine, etc.).
9) Use of supplements containing Glycyrrhiza, Cnidium rhizome, Angelicae root, Bupleuri root, Uncaria hook, Atractylodis lancea rhizome, Poria Sclerotium,
within 3 days prior to study drug administration.
10) Use of any agent within 7 days prior to study drug administration.
11) Subjects with abnormal clinical laboratory values inappropriate for the study in the opinion of the principal investigator/subinvestigator.
12) Subjects who are deemed ineligible for other reasons by the principal investigator/subinvestigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified