A Study to Compare Oral Absorption of YM060 Between Orall... | NCT01392794

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

NCT01392794

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jul 13, 2011Estimated

Enrollment

36Actual

Phase

Phase 1

Conditions

Healthy
Plasma Concentration of YM060

Interventions

YM060

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jul 11, 2011

First Submission Date that Met QC Criteria

Jul 11, 2011

First Posted Date

Jul 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2011

Last Update Posted Date

Jul 13, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
orally-disintegrating (OD) tablet precedence group	Experimental		Drug: YM060
conventional tablet precedence group	Experimental		Drug: YM060

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YM060	Drug	oral, without water	conventional tablet precedence group orally-disintegrating (OD) tablet precedence group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided