NCT01456624

Brief Summary

The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fasting and fed condition.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

June 25, 2014

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

October 19, 2011

Last Update Submit

June 23, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety (normal results for safety tests)

    Adverse events Physical examination, vital signs

    30days

Study Arms (4)

Megace / Fasting condition

ACTIVE COMPARATOR

800mg

Drug: Megace

DW-ES(B) / Fasting condition

EXPERIMENTAL

625mg

Drug: DW-ES(B)

Megace / Fed condition

ACTIVE COMPARATOR

800mg

Drug: Megace

DW-ES(B) / Fed condition

EXPERIMENTAL

625mg

Drug: DW-ES(B)

Interventions

MegaceDRUG

800mg

Megace / Fasting conditionMegace / Fed condition
DW-ES(B)DRUG

625mg

DW-ES(B) / Fasting conditionDW-ES(B) / Fed condition

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult males aged 20 to 40 years at screening.
  • No significant congenital/chronic disease. No symptoms in physical examination.
  • Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
  • Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

You may not qualify if:

  • History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
  • History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Links

MeSH Terms

Interventions

Megestrol Acetate

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 21, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Last Updated

June 25, 2014

Record last verified: 2014-06

Locations

KR(1)