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

Hypertension and Dyslipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933658
• Other study ID #: DW-1501-P101
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2016
• Last updated: October 12, 2016
• Start date: November 2015

Study information

• Verified date: October 2016
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 49 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension and Dyslipidemia

Intervention

Drug:
• Telmisartan

• Amlodipine

• Rosuvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	AUC of Reference 2		0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour	No
Primary	Cmax of Reference 2		0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour	No