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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01392794

Enrollment

Registered

2011-07-13

Start date

2011-04-30

Completion date

2011-05-31

Last updated

2011-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Plasma Concentration of YM060

Keywords

YM060, ramosetron, orally-disintegrating tablet, OD tablet, bioequivalence

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.

Interventions

DRUGYM060

oral, without water

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 44 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026