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

Hypertension With Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707899
• Other study ID #: JLP-1401-102-PK
• Status: Completed
• Phase: Phase 1
• Start date: December 13, 2018
• Est. completion date: May 22, 2019

Study information

• Verified date: October 2018
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 22, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension With Dyslipidemia

Intervention

Drug:
• JLP-1401
Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)
• Telmisartan/Amlodipine, Rosuvastatin
Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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