NCT02343250
Completed
Phase 1
A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers
ConditionsHypertension
Overview
- Phase
- Phase 1
- Intervention
- Cilnidipine/Valsartan
- Conditions
- Hypertension
- Sponsor
- IlDong Pharmaceutical Co Ltd
- Enrollment
- 54
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 20 and 40
- •Signed informed consent
Exclusion Criteria
- •Has a history of hypersensitivity to IP ingredients
- •Hypertension of hypotension
Arms & Interventions
Cinidipine/Valsartan tablet
Cinidipine/Valsartan tablet
Intervention: Cilnidipine/Valsartan
Cinidipine/Valsartan tablet
Cinidipine/Valsartan tablet
Intervention: Cilnidipine+Valsartan
Cilnidipine+Valsartan
coadministration of cilinidipine and valsartan
Intervention: Cilnidipine+Valsartan
Cilnidipine+Valsartan
coadministration of cilinidipine and valsartan
Intervention: Cilnidipine/Valsartan
Outcomes
Primary Outcomes
Cmax
Time Frame: 0~24hr
AUClast
Time Frame: 0~24hr
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