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

NCT ID: NCT04667624

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2020-05-18

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reference

TWYNSTA Tablet 80/5mg(Telmisartan/Amlodipine)

Group Type ACTIVE_COMPARATOR

Twynsta

Intervention Type DRUG

Manufactured by Boehringer Ingelheim

Test

LodienT Tablet 80/2.5mg(Telmisartan/S-amlodipine)

Group Type EXPERIMENTAL

LodineT

Intervention Type DRUG

•Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea

Interventions

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Twynsta

Manufactured by Boehringer Ingelheim

Intervention Type DRUG

LodineT

•Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy volunteers aged more than 19 years old
2. Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
3. 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.
4. 90mmHg≤SBP≤139mmHg and 60mmHg≤DBP≤89mmHg)
5. Body mass index (BMI) of 18-30kg/m2
6. Willing and able to provide written informed consent

Exclusion Criteria

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

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Metro Hospital

Anyang, Kyung Gi, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HL-LDNT-101

Identifier Type: -

Identifier Source: org_study_id