Study to Evaluate the Safety and PK of LODIENT Tablet 80/... | NCT04667624

Studies
Study to Evaluate the Safety and PK of LODIENT Tablet 80/2.5mg in Healthy Adult Volunteers

NCT04667624

Sponsor

Hanlim Pharm. Co., Ltd.

Status

Completed

Last Update Posted

Dec 16, 2020Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Hypertension

Interventions

Twynsta
LodineT

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

Dec 2020

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

Feb 29, 2020Actual

Primary Completion Date

Apr 28, 2020Actual

Completion Date

May 18, 2020Actual

First Submitted Date

Dec 8, 2020

First Submission Date that Met QC Criteria

Dec 8, 2020

First Posted Date

Dec 16, 2020Actual

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

Dec 8, 2020

Last Update Posted Date

Dec 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

A randomized, open label, single dose, 2-sequence, 4-period, cross-over phase I clinical trial to compare and evaluate the safety and pharmacokinetics after oral administration of "LodienT tablet 80/2.5mg(telmisartan/s-amlodipine)" and "TWINSTA tablet 80/5mg(telmisartan/amlodipine)" in healthy adult volunteers.

Detailed Description

Amlodipine is a drug which belongs to calcium channel blockers (CCBs) and is used to treat hypertension. The molecule contains one chiral carbon atom and exists as a racemic mixture. As only the S-enantiomer of amlodipine [S-amlodipine] shows the CCB effect and R-amlodipine is responsible for the development of peripheral edema, purifying S-amlodipine can reduce the incidences of peripheral edema and other side effects.

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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reference	Active Comparator	TWYNSTA Tablet 80/5mg(Telmisartan/Amlodipine)	Drug: Twynsta
Test	Experimental	LodienT Tablet 80/2.5mg(Telmisartan/S-amlodipine)	Drug: LodineT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Twynsta	Drug	Manufactured by Boehringer Ingelheim	Reference
LodineT

Measure	Description	Time Frame
AUCt		0(pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48 and 72hr
Cmax		0(pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48 and 72hr

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers aged more than 19 years old
Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam.
90mmHg≤SBP≤139mmHg and 60mmHg≤DBP≤89mmHg)
Body mass index (BMI) of 18-30kg/m2
Willing and able to provide written informed consent

Exclusion Criteria:

Administration of other drug than can modulate metabolic enzyme within 1 months prior to the scrrening day.
Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
Continued excessive use of alcohol(alcohol>21 cups/day) and severe heavy smoker (cigarette > 20 cigarettes per day)
Administration of other investigational products within 6 months prior to the first dosing
Subject with the following conditions in laboratory test : AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5
Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days
Subject who take a medication that affect to the pharmacokinetics of drug within 10 days
Subject with decision of non-participation through investigator's review

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases