Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers

An Open-label, Randomized, Two-sequence, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03461081

Enrollment

Registered

2018-03-09

Start date

2017-05-07

Completion date

2017-12-12

Last updated

2018-03-12

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

Conditions

Hypertension With Hyperlipidemia

Brief summary

study to evaluate drug-drug interaction following oral administration of telmisartan/amlodipine and atorvastatin in healthy adult volunteers

Interventions

DRUGtelmisartan/amlodipine and atorvastatin

Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 19\ 55 years healthy male * The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2 * Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion criteria

* Subjects who are allergic to investigational drug. * Subjects who have a medical history which can affect the clinical trial. * Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 70mmHg) * Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Design outcomes

Primary

Measure	Time frame
AUCτ of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin	Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours
Css,max of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin	Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours

Countries

South Korea

Outcome results

None listed

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