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

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hypertension With Dyslipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03707899

JLP-1401-102-PK

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Group I (JLP-1401)

Experimental group

Description:

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

Treatment:

Drug: Telmisartan/Amlodipine, Rosuvastatin

Drug: JLP-1401

Group II (Telmisartan/Amlodipine, Rosuvastatin)

Active Comparator group

Description:

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

Treatment:

Drug: Telmisartan/Amlodipine, Rosuvastatin

Drug: JLP-1401