Study to Evaluate the Safety and PK of LODIENT Tablet 80/2.5mg 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 PK After Oral Administration of LodienT Tablet 80/2.5mg and TWYNSTA Tablet 80/5mg in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04667624

Enrollment

Registered

2020-12-16

Start date

2020-02-29

Completion date

2020-05-18

Last updated

2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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 80/2.5mg(telmisartan/s-amlodipine) and TWINSTA tablet 80/5mg(telmisartan/amlodipine) in healthy adult volunteers.

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.

Interventions

DRUGTwynsta

Manufactured by Boehringer Ingelheim

DRUGLodineT

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUCt	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	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026