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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01392794
First received: July 11, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
Plasma Concentration of YM060
Drug: YM060
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion Without Water

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Area under the curve of YM060 plasma concentration -time curve [ Time Frame: up to 24 hours after administration ] [ Designated as safety issue: No ]
  • Maximal concentration of YM060 plasma concentration [ Time Frame: up to 24 hours after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG [ Time Frame: up to 24 hours after administration ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: April 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: orally-disintegrating (OD) tablet precedence group Drug: YM060
oral, without water
Other Names:
  • ramosetron
  • Irribow
Experimental: conventional tablet precedence group Drug: YM060
oral, without water
Other Names:
  • ramosetron
  • Irribow

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392794

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01392794     History of Changes
Other Study ID Numbers: 060-CL-208
Study First Received: July 11, 2011
Last Updated: July 11, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
YM060
ramosetron
orally-disintegrating tablet
OD tablet
bioequivalence

Additional relevant MeSH terms:
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014