A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01392794
• Date of registration: 11/07/2011
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Inc
• Public title: A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet
• Scientific title: Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion Without Water
• Date of first enrolment: April 2011
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01392794
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Use Central Contact
• Affiliation: Astellas Pharma Inc

Key inclusion & exclusion criteria

Inclusion Criteria:

- healthy assessed by the principal investigator or sub-investigators

- non-smoking or stop smoking at least 90 days before the study

- body weight: over 50.0kg and less than 80.0kg

- body mass index (BMI): over 17.6 and less than 26.4

Exclusion Criteria:

- participated in another clinical trial (including a post-marketing clinical study)
within 120 days before the study

- donated 400mL of whole blood within 90 days, 200mL of whole blood within 30 days or
blood components within 14 days before the study

- received any drugs within 7 days before the study or going to receive any drugs

- deviance from normal range in vital signs (blood pressure, pulse rate, and body
temperature) or 12-lead ECG

- deviance from normal range in lab-tests

- history of drug allergy

- history or current diagnosis of stomach, small intestine or large intestine diseases

- history or current diagnosis of inflammatory bowel disease (Crohn's disease or
colitis ulcerative)

- history or current diagnosis of colitis ischemic

- history or current diagnosis of hepatic diseases

- history or current diagnosis of cardiovascular diseases

- history or current diagnosis of respiratory diseases

- history or current diagnosis of malignant tumor

- received ramosetron tablet



Age minimum: 20 Years
Age maximum: 44 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Plasma Concentration of YM060

Intervention(s)

Drug: YM060

Primary Outcome(s)

Area under the curve of YM060 plasma concentration -time curve [Time Frame: up to 24 hours after administration]

Maximal concentration of YM060 plasma concentration [Time Frame: up to 24 hours after administration]

Secondary Outcome(s)

Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG [Time Frame: up to 24 hours after administration]

Secondary ID(s)

060-CL-208

Source(s) of Monetary Support

Please refer to primary and secondary sponsors