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

Phase 1

Completed

• Conditions: Hypertension With Dyslipidemia
• Interventions: Drug: JLP-1401; Drug: Telmisartan/Amlodipine, Rosuvastatin

• Registration Number: NCT03707899
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-14
• Study First Submitted QC: 2018-10-14
• Study First Posted: 2018-10-16
• Study Start: 2018-12-13
• Primary Completion: 2019-02-18
• Study Completion: 2019-05-22
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group II (Telmisartan/Amlodipine, Rosuvastatin)	Telmisartan/Amlodipine, Rosuvastatin	Twinsta(Telmisartan 80 mg, amlodipine 5 mg) and Crestor(rosuvastatin 5 mg)
Group I (JLP-1401)	JLP-1401	JLP-1401(Telmisartan 80 mg, amlodipine 5 mg, rosuvastatin 5 mg)
Group I (JLP-1401)	Telmisartan/Amlodipine, Rosuvastatin	JLP-1401(Telmisartan 80 mg, amlodipine 5 mg, rosuvastatin 5 mg)
Group II (Telmisartan/Amlodipine, Rosuvastatin)	JLP-1401	Twinsta(Telmisartan 80 mg, amlodipine 5 mg) and Crestor(rosuvastatin 5 mg)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of