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

To investigate the pharmacokinetic Drug-drug interaction

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteer
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Telmisartan; Drug: Amlodipine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Pusan, Korea, Republic of
    • Dong-A University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: telmisartan, Amlodipine, 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	Drug: Rosuvastatin; Drug: Telmisartan; Drug: Amlodipine
Experimental: Telmisartan, Amlodipine, 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	Drug: Rosuvastatin; Drug: Telmisartan; Drug: Amlodipine

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Minkgyu Park, Ph.D, M.D., Dong-A university hospital of Korea

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: September 3, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 16, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Rosuvastatin Calcium; Telmisartan
• Other Study ID Numbers: YH22189-101