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

• Status: Completed
• Trial end date: 2020-05-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Telmisartan amlodipine combination

Criteria

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