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

Phase 1

Completed

• Conditions: Healthy Male Volunteer
• Interventions: Drug: Telmisartan; Drug: Amlodipine; Drug: Rosuvastatin

• Registration Number: NCT02233218
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-08
• Primary Completion: 2014-10
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-16
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
telmisartan, Amlodipine, Rosuvastatin	Amlodipine	This arm is consist of 40 subjects. Telmisartan80mg + Amlodipine 10mg 9 days, Telmisartan80mg + Amlodipine 10mg , Rosuvastatin 20mg 5days Total 14days administration of investigational products to healthy male volunteers
telmisartan, Amlodipine, Rosuvastatin	Telmisartan	This arm is consist of 40 subjects. Telmisartan80mg + Amlodipine 10mg 9 days, Telmisartan80mg + Amlodipine 10mg , Rosuvastatin 20mg 5days Total 14days administration of investigational products to healthy male volunteers
telmisartan, Amlodipine, Rosuvastatin	Rosuvastatin	This arm is consist of 40 subjects. Telmisartan80mg + Amlodipine 10mg 9 days, Telmisartan80mg + Amlodipine 10mg , Rosuvastatin 20mg 5days Total 14days administration of investigational products to healthy male volunteers
Telmisartan, Amlodipine, Rosuvastatin	Telmisartan	This arm is consist of 20 subjects. Rosuvastatin 20mg 5 days, Rosuvastatin 20mg , Telmisartan80mg + Amlodipine 10mg 9days, Total 14days administration of investigational products to healthy male volunteers
Telmisartan, Amlodipine, Rosuvastatin	Rosuvastatin	This arm is consist of 20 subjects. Rosuvastatin 20mg 5 days, Rosuvastatin 20mg , Telmisartan80mg + Amlodipine 10mg 9days, Total 14days administration of investigational products to healthy male volunteers
Telmisartan, Amlodipine, Rosuvastatin	Amlodipine	This arm is consist of 20 subjects. Rosuvastatin 20mg 5 days, Rosuvastatin 20mg , Telmisartan80mg + Amlodipine 10mg 9days, Total 14days administration of investigational products to healthy male volunteers

Primary Outcome Measures

Name	Time	Method
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)
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 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)

Secondary Outcome Measures

Name	Time	Method
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 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)
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)
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)

Trial Locations

Locations (1)

Dong-A university hospital; 🇰🇷 Pusan, Korea, Republic of