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Completed

NCT Number: NCT01392794

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

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.

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Key information

Conditions

Healthy Plasma Concentration of YM060

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YM060

Drug

oral, without water

Other names: ramosetron, Irribow

Primary outcomes

  1. Area under the curve of YM060 plasma concentration -time curve

    Time frame: up to 24 hours after administration

  2. Maximal concentration of YM060 plasma concentration

    Time frame: up to 24 hours after administration

Secondary outcomes

  1. Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG

    Time frame: up to 24 hours after administration

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 13, 2011
Registry last updated
Jul 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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