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

NCT04667624 | Completed Phase 1

• 1 other identifier: HL-LDNT-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Reference

ACTIVE COMPARATOR

TWYNSTA Tablet 80/5mg(Telmisartan/Amlodipine)

Drug: Twynsta

Test

EXPERIMENTAL

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

Drug: LodineT

Interventions

Twynsta DRUG

Manufactured by Boehringer Ingelheim

Reference

LodineT DRUG

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

Test

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• mmHg≤SBP≤139mmHg and 60mmHg≤DBP≤89mmHg)
• Body mass index (BMI) of 18-30kg/m2
• Willing and able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Metro Hospital

Anyang, Kyung Gi, 430-720, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

telmisartan amlodipine combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: February 29, 2020
• Primary Completion: April 28, 2020
• Study Completion: May 18, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)