Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Vo... | NCT01456624

Studies
Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fasting and Fed Condition

NCT01456624

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Jun 25, 2014Estimated

Enrollment

56Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Megace
DW-ES(B)

Countries

South Korea

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

Jun 2014

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

Sep 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Not provided

First Submitted Date

Oct 19, 2011

First Submission Date that Met QC Criteria

Oct 19, 2011

First Posted Date

Oct 21, 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

Jun 23, 2014

Last Update Posted Date

Jun 25, 2014Estimated

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

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.

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

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Megace	Drug	800mg	Megace / Fasting condition Megace / Fed condition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety (normal results for safety tests)	Adverse events Physical examination, vital signs	30days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Label	URL
Clinical Research Center, Asan Medical Center	View source

Intervention Browse Module

MeSH Terms

ID	Term
D019290	Megestrol Acetate

Ancestor Terms

ID	Term
D008535	Megestrol
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided