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Effect of ingested water volume on the pharmacokinetics of acidic or basic drugs after administered as orally disintegrating tablets

Effect of ingested water volume on the pharmacokinetics of acidic or basic drugs after administered as orally disintegrating tablets - Effect of ingested water volume on the pharmacokinetics of drugs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015083
Enrollment
12
Registered
2014-09-08
Start date
2014-09-19
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

digestive disorder

Interventions

Number of subjects : 12 Period of study: 2 days 1) Volunteers are fasted overnight. 2) Volunteers are administered three kinds of drugs (Pitavastatin calcium, Glimepiride, Lansoprazole) orally a

Sponsors

Faculty of Pharmaceutical Sciences, Setsunan University
Lead Sponsor
Towa Pharmaceutical Co. Ltd.
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Men, Japanese, If students, this volunteer shop does not affect the required course in their University. 2) BMI is 18.5>= and <25.0.

Exclusion criteria

Exclusion criteria: 1)Who having (or had) a medical history of circulatory system disease, hepatic disease, renal disease, digestive system disease, hematological disorder. 2)Who taking a medicine that night affect the study result. 3)Who judged as inappropriate to this study by the primary doctor of this study from diagnosis, vital signs, inductive electrocardiograph, hematological assessment, blood biochemical test, urinary test, immunological test. 4)Who took a medicine within 7 days before the study 5)Who participated in the clinical trail and took a test medicine within 3 months before the study. 6)Who having (or had) an allergic constitution to medicine/food 7)Who having (or had) a dependency to drug or alcohol 8)Who judged as inappropriate to this study by the primary doctor due to any other reasons

Design outcomes

Primary

MeasureTime frame
Blood concentration profile of each drug after oral administration with or without water ingestion.

Countries

Japan

Contacts

Public ContactShinji Yamashita

Setsunan University Faculty of Pharmaceutical Sciences

shinji@pharm.setsunan.ac.jp072-866-3125

Outcome results

None listed

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