Study to Evaluate the Safety and PK of LODIENT Tablet 80/2.5mg in Healthy Adult Volunteers
December 8, 2020 updated by: Hanlim Pharm. Co., Ltd.
A Randomized, Open Label, Single Dose, 2-sequence, 4-period, Cross-over Phase I Clinical Trial to Compare and Evaluate the Safety and PK After Oral Administration of "LodienT Tablet 80/2.5mg" and "TWYNSTA Tablet 80/5mg" in Healthy Adult Volunteers
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kyung Gi
-
Anyang, Kyung Gi, Korea, Republic of, 430-720
- Metro Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Reference
TWYNSTA Tablet 80/5mg(Telmisartan/Amlodipine)
|
Manufactured by Boehringer Ingelheim
|
|
EXPERIMENTAL: Test
LodienT Tablet 80/2.5mg(Telmisartan/S-amlodipine)
|
•Manufactured by Hanlim Pharm.
Co., Ltd, Seoul, Korea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
AUCt
Time Frame: 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
|
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
Time Frame: 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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 29, 2020
Primary Completion (ACTUAL)
April 28, 2020
Study Completion (ACTUAL)
May 18, 2020
Study Registration Dates
First Submitted
December 8, 2020
First Submitted That Met QC Criteria
December 8, 2020
First Posted (ACTUAL)
December 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 16, 2020
Last Update Submitted That Met QC Criteria
December 8, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL-LDNT-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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