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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667624
• Other study ID #: HL-LDNT-101
• Status: Completed
• Phase: Phase 1
• Start date: February 29, 2020
• Est. completion date: May 18, 2020

Study information

• Verified date: December 2020
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 18, 2020
• Est. primary completion date: April 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Twynsta
Manufactured by Boehringer Ingelheim
• LodineT
•Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea

Locations

Country	Name	City	State
Korea, Republic of	Metro Hospital	Anyang	Kyung Gi

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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