A Bioequivalence Study of Amlodipine Plus Losartan Versus... | NCT01197001

Studies
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

NCT01197001

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Apr 27, 2011Estimated

Enrollment

72Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

Amlodipine plus Losartan
Amlodipine, Losartan

Countries

Czechia

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

Apr 2011

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

Aug 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Sep 7, 2010

First Submission Date that Met QC Criteria

Sep 7, 2010

First Posted Date

Sep 9, 2010Estimated

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 26, 2011

Last Update Posted Date

Apr 27, 2011Estimated

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

Study Design :

A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study

Primary Objective:

To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan

Detailed Description

Secondary Objective:

To evaluate the safety and tolerability of these formulations.

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

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amlodipine plus Losartan	Experimental		Drug: Amlodipine plus Losartan
Amlodipine, Losartan	Active Comparator		Drug: Amlodipine, Losartan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amlodipine plus Losartan	Drug	Amlodipine/Losartan low dose	Amlodipine plus Losartan

Measure	Description	Time Frame
AUC, Cmax		0-144hrs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-55 years
Healthy Caucasian volunteers
Non smokers or mild smokers

Exclusion criteria:

Pregnancy and/or breast-feeding
Participation in another clinical trial within 60 days prior to Period 1.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CEPHA s.r.o.		Pilsen		CZ-323 00	Czechia

Intervention Browse Module

MeSH Terms

ID	Term
D017311	Amlodipine
D019808	Losartan
C000710253	amlodipine-losartan drug combination

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided