Clinical Trial to Investigate the Pharmacokinetic Drug In... | NCT01928563

Studies
Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine

NCT01928563

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Aug 26, 2013Estimated

Enrollment

24Estimated

Phase

Phase 1

Conditions

Healthy Male Subjects

Interventions

Dapoxetine
Udenafil
Udenafil+Dapoxetine

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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Aug 21, 2013

First Submission Date that Met QC Criteria

Aug 21, 2013

First Posted Date

Aug 26, 2013Estimated

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

Aug 21, 2013

Last Update Posted Date

Aug 26, 2013Estimated

Name	Class
Dong-A ST Co., Ltd.	INDUSTRY

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

This study is designed to investigate the pharmacokinetic drug interaction between Udenafil and Dapoxetine in healthy male subjects

Design : Randomized, open-label, 3-treatment, 6-sequence, 3-period crossover study

Investigational Product : Udenafil, Dapoxetine

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

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dapoxetine	Experimental	Dapoxetine is administered	Drug: Dapoxetine
Udenafil	Experimental	Udenafil is administered	Drug: Udenafil
Udenafil and Dapoxetine	Experimental	Udenafil and Dapoxetine are co-administered	Drug: Udenafil+Dapoxetine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dapoxetine	Drug		Dapoxetine	Brand name : Priligy Dapoxetine is administered

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax and AUClast of Udenafil and Dapoxetine		Blood gathering point : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h (each period)

Secondary Outcomes

Measure	Description	Time Frame
AUC0-00, Tmax, T1/2β of Udenafil and Dapoxetine AUClast, Cmax, Tmax, t1/2β of DA-8164(major metabolite of Udenafil) and Desmethyl dapoxetine(major metabolite of Dapoxetine)		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h (each period)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male volunteers in the age between 20 and 45 years old at screening
Body mass index(BMI) in the range of 19 to 27 ㎏/㎡
Sitting position blood pressure down to meet the criteria at the time of screening (90mmHg≤Systolic blood pressure≤140mmHg)

Exclusion Criteria:

History of clinically significant disease or kidney, liver and biliary system, digestive system, respiratory, musculoskeletal, endocrine, neurological psychiatric blood and tumor system, cardiovascular system, etc.
History of gastrointestinal diseases or gastrointestinal operation which might affect the study drug absorption
Clinically significant hypersensitivity or with a history of hypersensitivity reactions to Udenafil, Dapoxetine ingredients that included elements of the same family of drugs, or other medications
≥ 1.5 fold of normal upper limit(UNL) in the level of ALT, AST
Alcohol, excessive intake (>21 units/week)
Excessive smoker (>10 cigarette/day)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yong-Goo Bae, MSc	Contact	+82-2-920-8521		byg@donga.co.kr

Overall Officials

Name	Affiliation	Role
Kyun-Seop Bae, M.D., Ph.D.	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul	Songpa-gu	138-786	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C080598	dapoxetine
C419664	udenafil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided