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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02933658
Enrollment
71
Registered
2016-10-14
Start date
2015-11-30
Completion date
Unknown
Last updated
2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension and Dyslipidemia

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

Interventions

DRUGTelmisartan
DRUGAmlodipine
DRUGRosuvastatin

Sponsors

Daewon Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
AUC of Reference 10, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 10, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
AUC of Reference 20.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 20.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026