Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Hypertension and Dyslipidemia
• Interventions: Drug: Telmisartan; Drug: Amlodipine; Drug: Rosuvastatin

• Registration Number: NCT02933658
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2015-11
• Status Verified: 2016-10
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-12
• Last Update Submitted: 2016-10-12
• Study First Posted: 2016-10-14
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 71

Inclusion Criteria

• Healthy male who are ≥19, <50 years old
• Man who weights over 55kg and whose BMI is 18~30(kg/m2)
• Man who doesn't have any chronic disease or history of disease

Exclusion Criteria

• man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference2	Rosuvastatin	single(Reference2) -\> combination(Reference1+Reference2)
Reference1	Telmisartan	single(Reference1) -\> combination(Reference1+Reference2)
Reference1	Amlodipine	single(Reference1) -\> combination(Reference1+Reference2)
Reference1	Rosuvastatin	single(Reference1) -\> combination(Reference1+Reference2)
Reference2	Telmisartan	single(Reference2) -\> combination(Reference1+Reference2)
Reference2	Amlodipine	single(Reference2) -\> combination(Reference1+Reference2)

Primary Outcome Measures

Name	Time	Method
AUC of Reference 2	0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
AUC of Reference 1	0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 1	0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 2	0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour