The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers Volunteers

An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03707899

Enrollment

Registered

2018-10-16

Start date

2018-12-13

Completion date

2019-05-22

Last updated

2019-08-29

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

Conditions

Hypertension With Dyslipidemia

Brief summary

The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers.

Interventions

DRUGJLP-1401

Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)

DRUGTelmisartan/Amlodipine, Rosuvastatin

Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2 * Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial * Subject who has the ability and willingness to participate the whole period of trial

Exclusion criteria

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. * Subjects who are allergic to investigational drug. * Subjects who have a medical history which can affect the clinical trial. * SBP \< 90 mmHG, SBP \> 140mmHG or DBP \< 60 mmHG, DBP \> 100mmHg * AST or ALT \> X 2 UNL * CK \> X 2 UNL * History of drug abuse or positive drug screening. * Participation in other drug studies within 3 months prior to the drug administration. * Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Design outcomes

Primary

Measure	Time frame	Description
AUCt	72 hr after baseline	Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Cmax	72 hr after baseline	Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline

Countries

South Korea

Outcome results

None listed

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