Pharmacokinetics of Megace F and Megace OS Under Fasting... | NCT01397214

Studies
Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers

NCT01397214

Sponsor

Boryung Pharmaceutical Co., Ltd

Status

Completed

Last Update Posted

Jul 2, 2012Estimated

Enrollment

103Actual

Phase

Phase 1

Conditions

Cachexia
Anorexia

Interventions

Megace F
Megace OS

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 2012

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

Jul 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jul 15, 2011

First Submission Date that Met QC Criteria

Jul 18, 2011

First Posted Date

Jul 19, 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 29, 2012

Last Update Posted Date

Jul 2, 2012Estimated

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

Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety compared to Megace OS.

Phase I study divided into 3 parts written as belows.

Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers

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

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Megace F	Experimental	Megace F oral suspension	Drug: Megace F
Megace OS	Active Comparator	Megace acetate oral suspension	Drug: Megace OS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Megace F	Drug	Megace F oral suspension	Megace F
Megace OS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC		0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs

Secondary Outcomes

Measure	Description	Time Frame
Tmax		0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs
t1/2		0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age: 20-55 years body weight: greater than 50kg written informed consent

Exclusion Criteria:

known allergy to Megesterol acute or chronic diseases which could affect drug absorption or metabolism positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 3 months prior to the start of the study

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung-sang Yu, Dr.	Seoul National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002100	Cachexia
D000855	Anorexia

Ancestor Terms

ID	Term
D015431	Weight Loss
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided