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

Healthy Male Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233218
• Other study ID #: YH22189-101
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2014
• Last updated: February 16, 2015
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

To investigate the pharmacokinetic Drug-drug interaction

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy Male Volunteer

Intervention

Drug:
• Telmisartan

• Amlodipine

• Rosuvastatin

Locations

Country	Name	City	State
Korea, Republic of	Dong-A university hospital	Pusan

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No