Status:
COMPLETED
Study to Evaluate the Safety and PK of LODIENT Tablet 80/2.5mg in Healthy Adult Volunteers
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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...
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-ena...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04667624
Start Date
February 29 2020
End Date
May 18 2020
Last Update
December 16 2020
Active Locations (1)
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1
Metro Hospital
Anyang, Kyung Gi, South Korea, 430-720