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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- AUCt
Study Overview
Brief Summary
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Adult Volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group I (JLP-1401)
JLP-1401(Telmisartan 80 mg, amlodipine 5 mg, rosuvastatin 5 mg)
Intervention: JLP-1401 (Drug)
Group I (JLP-1401)
JLP-1401(Telmisartan 80 mg, amlodipine 5 mg, rosuvastatin 5 mg)
Intervention: Telmisartan/Amlodipine, Rosuvastatin (Drug)
Group II (Telmisartan/Amlodipine, Rosuvastatin)
Twinsta(Telmisartan 80 mg, amlodipine 5 mg) and Crestor(rosuvastatin 5 mg)
Intervention: JLP-1401 (Drug)
Group II (Telmisartan/Amlodipine, Rosuvastatin)
Twinsta(Telmisartan 80 mg, amlodipine 5 mg) and Crestor(rosuvastatin 5 mg)
Intervention: Telmisartan/Amlodipine, Rosuvastatin (Drug)
Outcomes
Primary Outcomes
AUCt
Time Frame: 72 hr after baseline
Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Cmax
Time Frame: 72 hr after baseline
Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Secondary Outcomes
No secondary outcomes reported