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

NCT03707899 | Completed Phase 1

• 1 other identifier: JLP-1401-102-PK
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension With Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group I (JLP-1401)

EXPERIMENTAL

JLP-1401(Telmisartan 80 mg, amlodipine 5 mg, rosuvastatin 5 mg)

Drug: JLP-1401; Drug: Telmisartan/Amlodipine, Rosuvastatin

Group II (Telmisartan/Amlodipine, Rosuvastatin)

ACTIVE COMPARATOR

Twinsta(Telmisartan 80 mg, amlodipine 5 mg) and Crestor(rosuvastatin 5 mg)

Drug: JLP-1401; Drug: Telmisartan/Amlodipine, Rosuvastatin

Interventions

JLP-1401 DRUG

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

Group I (JLP-1401); Group II (Telmisartan/Amlodipine, Rosuvastatin)

Telmisartan/Amlodipine, Rosuvastatin DRUG

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

Group I (JLP-1401); Group II (Telmisartan/Amlodipine, Rosuvastatin)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Interventions

Telmisartan; Amlodipine; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 16, 2018
• Study Start: December 13, 2018
• Primary Completion: February 18, 2019
• Study Completion: May 22, 2019
• Last Updated: August 29, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)