Safety and Pharmacokinetics Study of amlodipine10mg and c... | NCT01806311

Studies
Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

NCT01806311

Sponsor

HanAll BioPharma Co., Ltd.

Status

Completed

Last Update Posted

Apr 20, 2025Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

Hypertension

Interventions

Candesartan32mg
Amlodipine10mg

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

Feb 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

Dec 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Mar 4, 2013

First Submission Date that Met QC Criteria

Mar 5, 2013

First Posted Date

Mar 7, 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

Apr 16, 2025

Last Update Posted Date

Apr 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in healthy male 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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PartA: Candesartan, Candesartan + Amolodipine	Active Comparator	Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally	Drug: Candesartan32mg Drug: Amlodipine10mg
PartB: Amlodipine, Amlodipine+Candesartan	Active Comparator	Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally	Drug: Candesartan32mg Drug: Amlodipine10mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Candesartan32mg	Drug		PartA: Candesartan, Candesartan + Amolodipine PartB: Amlodipine, Amlodipine+Candesartan
Amlodipine10mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A : AUC, Cmax of Candesartan		Over a 24-hour sampling period
Par B : AUC, Cmax of Amlodipine		Over a 24-hour sampling period

Secondary Outcomes

Measure	Description	Time Frame
PartA: Cmin, tmax, CL/F of Candesartan		Over a 24-hour sampling period
PartB: Cmin, tmax, CL/F of Amlodipine		Over a 24-hour sampling period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male, Age 20 to 45
Subject must be willing and able to provide written informed consent to the study.

Exclusion Criteria:

History of any significant sickness, liver system, gall bladder system, kidney, nerve system, respiratory system, blood tumor, endocrine system, urinary system, mental disease, muscloskeletal system, immunity system, the ear, nose and throat system and cardiovascular system.
History of any significant gastrointestinal system and surgery of gastrointestinal.
History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic.
Over 10 tobaccos a day.
Other condition which in the opinion of the investigator preclude endrollment into the study.

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

Not provided

Overall Officials

Name	Affiliation	Role
Jang Hee Hong, Associate Professor	Chungnam national university hospital, Clinical trial center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chungnam national university hospital,clinical trial center		Daejeon	Chungcheongbul-do	301-721	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided