Clinical trial NCT04667624: Study to Evaluate the Safety and PK of LODIENT Tablet 80/2.5mg in Healthy Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-16
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: AUCt
timeFrame: 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
measure: Cmax
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Metro Hospital
state: Kyung Gi
Study officials:
References: