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

July 11, 2011 updated by: Astellas Pharma Inc

Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion Without Water

A study to compare time-course changes of plasma concentration of YM060 after intake of conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be administered without water.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: orally-disintegrating (OD) tablet precedence group
Drug: YM060
oral, without water
Other Names:
  • Irribow
  • ramosetron
Experimental: conventional tablet precedence group
Drug: YM060
oral, without water
Other Names:
  • Irribow
  • ramosetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve of YM060 plasma concentration -time curve
Time Frame: up to 24 hours after administration
up to 24 hours after administration
Maximal concentration of YM060 plasma concentration
Time Frame: up to 24 hours after administration
up to 24 hours after administration

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 13, 2011

Study Record Updates

Last Update Posted (Estimate)

July 13, 2011

Last Update Submitted That Met QC Criteria

July 11, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060-CL-208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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