A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet and Conventional Tablet Under With Water Intake

Healthy Clinical Trial

Official title:

Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion With Water -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394653
• Other study ID #: 060-CL-209
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2011
• Last updated: October 10, 2011
• Start date: July 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating tablet with those of conventional tablet. Tablets will be administered with water.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy
• Plasma Concentration of YM060

Intervention

Drug:
• YM060
oral, with water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of YM060 plasma concentration -time curve		up to 24 hours after administration	No
Primary	Maximal concentration of YM060 plasma concentration		up to 24 hours after administration	No
Secondary	Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG		up to 24 hours after administration	No