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

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

Study Overview

• Status: Completed
• Conditions: Hypertension With Dyslipidemia
• Intervention / Treatment: Drug: JLP-1401; Drug: Telmisartan/Amlodipine, Rosuvastatin

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group I (JLP-1401); JLP-1401(Telmisartan 80 mg, amlodipine 5 mg, rosuvastatin 5 mg)	Drug: JLP-1401; Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin); Drug: Telmisartan/Amlodipine, Rosuvastatin; Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)
ACTIVE_COMPARATOR: Group II (Telmisartan/Amlodipine, Rosuvastatin); Twinsta(Telmisartan 80 mg, amlodipine 5 mg) and Crestor(rosuvastatin 5 mg)	Drug: JLP-1401; Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin); Drug: Telmisartan/Amlodipine, Rosuvastatin; Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 13, 2018
• Primary Completion (ACTUAL): February 18, 2019
• Study Completion (ACTUAL): May 22, 2019

Study Registration Dates

• First Submitted: October 14, 2018
• First Submitted That Met QC Criteria: October 14, 2018
• First Posted (ACTUAL): October 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Rosuvastatin Calcium; Telmisartan; Telmisartan amlodipine combination
• Other Study ID Numbers: JLP-1401-102-PK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No