The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

A Phase 1, Open Label, Non-randomized, Two-cohort, Single-sequence, Crossover Study to Investigate the Pharmacokinetic Drug-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

NCT02233218

Enrollment

Registered

2014-09-08

Start date

2014-07-31

Completion date

2015-01-31

Last updated

2015-02-18

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

Conditions

Healthy Male Volunteer

Brief summary

To investigate the pharmacokinetic Drug-drug interaction

Detailed description

The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan, amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.

Interventions

DRUGTelmisartan

DRUGAmlodipine

DRUGRosuvastatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy male volunteers aged 19 to 50 2. Participant who has a body weight that is \>=55kg(male) and body mass index (BMI) level that is 18\ 30 3. Provision of signed written informed consent

Exclusion criteria

1. History of clinically significant disease 2. History of clinically significant hypersensitivity or hypersensitivity reactions to drugs and other medications (aspirin, antibiotics, etc.), including components such as Telmisartan, Rosuvastatin and Amlodipine 3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs 4. Administration of other investigational products within 2 months prior to the first dosing. 5. Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study) 6. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to the reasons including laboratory test results, ECGs, or vital signs.

Design outcomes

Primary

Measure	Time frame
Area under the plasma/serum/blood drug concentration-time curve in steady-state of Telmisartan and Amlodipine	0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Maximum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine	0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Area under the plasma/serum/blood drug concentration-time curve in steady-state of Rosuvastatin	0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Maximum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin	0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

Secondary

Measure	Time frame
Time of peak concentration in steady state of rosuvastatin and N- desmethyl rosuvastatin	0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Time of peak concentration in steady state of Telmisartan and Amlodipine	0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Minimum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin and N- desmethyl rosuvastatin	0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Minimum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine	0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Area under the plasma/serum/blood drug concentration-time curve in steady-state of N- desmethyl rosuvastatin	0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Maximum concentration of drug in plasma/serum/blood in steady-state of N- desmethyl rosuvastatin	0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

Countries

South Korea

Outcome results

None listed

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