A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin

A Phase 1, Open Label, Two-cohort, Single-Sequence, Crossover Study to Investigate the Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02951962

Enrollment

Registered

2016-11-01

Start date

2016-08-31

Completion date

2016-09-30

Last updated

2017-02-01

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

Conditions

Hyperlipidemia, Hypertension

Brief summary

This is a phase 1, open label, two-cohort, single-sequence, crossover study

Detailed description

This is a phase 1, open label, two-cohort, single-sequence, crossover study to investigate the pharmacokinetic drug interaction and safety of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers.

Interventions

DRUGTwynsta 80/5mg

Hypertension

DRUGCrestor 20mg

Hyperlipidemia

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male with body mass index(BMI) between 18.5 and 28 kg/m2 * Who has not suffered from clinically significant disease * Provision of signed written informed consent

Exclusion criteria

* History of and clinically significant disease * A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs * Administration of other investigational products within 3 months prior to the first dosing * Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs * Sitting blood pressure meeting the following criteria at screening: 160 ≥ systolic blood pressure ≤100 (mmHg) and 95 ≥ diastolic blood pressure ≤ 60 (mmHg)

Design outcomes

Primary

Measure	Time frame
Telmisartan, Amlodipine, Rosuvastatin AUCτ	0 - 24 hr
Telmisartan, Amlodipine, Rosuvastatin Cmax	0 - 24 hr

Secondary

Measure	Time frame
Telmisartan, Amlodipine, Rosuvastatin Tmax	0 - 24 hr
Telmisartan, Amlodipine, Rosuvastatin Cmin	0 - 24 hr

Countries

South Korea

Outcome results

None listed

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