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

Hanlim Pharm

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: LodineT; Drug: Twynsta

Study type: Interventional

Funder types: Industry

Identifiers

NCT04667624

HL-LDNT-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Reference

Active Comparator group

Description:

TWYNSTA Tablet 80/5mg(Telmisartan/Amlodipine)

Treatment:

Drug: Twynsta

Test

Experimental group

Description:

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

Treatment:

Drug: LodineT