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

NCT02233218 | Completed Phase 1

• 1 other identifier: YH22189-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the pharmacokinetic Drug-drug interaction

Conditions

Healthy Male Volunteer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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)

Study Arms (2)

telmisartan, Amlodipine, Rosuvastatin

EXPERIMENTAL

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: Telmisartan; Drug: Amlodipine; Drug: Rosuvastatin

Telmisartan, Amlodipine, Rosuvastatin

EXPERIMENTAL

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: Telmisartan; Drug: Amlodipine; Drug: Rosuvastatin

Interventions

Telmisartan DRUG

Telmisartan, Amlodipine, Rosuvastatin; telmisartan, Amlodipine, Rosuvastatin

Amlodipine DRUG

Telmisartan, Amlodipine, Rosuvastatin; telmisartan, Amlodipine, Rosuvastatin

Rosuvastatin DRUG

Telmisartan, Amlodipine, Rosuvastatin; telmisartan, Amlodipine, Rosuvastatin

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of clinically significant disease
• History of clinically significant hypersensitivity or hypersensitivity reactions to drugs and other medications (aspirin, antibiotics, etc.), including components such as Telmisartan, Rosuvastatin and Amlodipine
• 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 2 months prior to the first dosing.
• 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)
• 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.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Dong-A university hospital

Pusan, South Korea

Location

MeSH Terms

Interventions

Telmisartan; Amlodipine; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Minkgyu Park, Ph.D, M.D.

  Dong-A university hospital of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: September 8, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

KR (1)