To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers

• Sponsor: Samil Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02579356
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 4
• Duration (Months): 3
• Patients Per Site Per Month: 15.9

Study Details

Study Description

Brief Summary

The study design was composed of 2 parts, 2-way crossover and multiple-dose. There are having 2 groups in each part that have divided period 1 and period 2, and wash-out period is 16 days between periods. Each group is taking Telmisartan (80mg) and/or Atorvastatin (80mg) once a day for 6 days.

Condition or Disease	Intervention/Treatment	Phase
Diseases of the Circulatory System; Essential Hypertension	Drug: Telmisartan; Drug: Atorvastatin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part1-A The Part1-A of groups take Telmisartan once a day for 6 days in period 1. After wash-out period, they take Telmisartan and Atorvastatin once a day for 6 days in period 2.	Drug: Telmisartan; Drug: Atorvastatin
Experimental: Part1-B The Part1-B of groups take Telmisartan and Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Telmisartan once a day for 6 days in period 2.	Drug: Telmisartan; Drug: Atorvastatin
Experimental: Part2-A The Part2-A of groups take Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Telmisartan and Atorvastatin once a day for 6 days in period 2.	Drug: Telmisartan; Drug: Atorvastatin
Experimental: Part2-B The Part2-B of groups take Telmisartan and Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Atorvastatin once a day for 6 days in period 2.	Drug: Telmisartan; Drug: Atorvastatin

Outcome Measures

Primary Outcome Measures

1. AUCt(0-24) [First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)]

2. Css,max [First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)]

Secondary Outcome Measures

1. Css,min [First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)]

2. Css,av [First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)]

3. Tss,max [First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)]

4. t1/2 [First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)]

5. CL/F [First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)]

6. Vd/F [First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male subjects between the ages of 19 and 55 years

• Subjects who don't have congenital or chronic diseases and have no abnormal medical examination results within 3 years

• Healthy Subjects (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator

• Subjects who signed and dated in informed consent form indicating that the subject has decided to participate in the study after being informed of all pertinent aspects of the study

• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

• Any condition possibly affecting drug absorption, distribution, metabolism, and excretion (e.g. gastrectomy)

• Twofold or more than upper limit of normal range in laboratory test for ALT or AST

• Participating in other clinical trial study within 2 month preceding the first dose of investigational product

• History of significant alcohol abuse or drug abuse within one year prior to the screening

• Whole blood donation within 2 months prior to dosing, or apheresis donation within 1 month prior to dosing

• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study

• Unwilling or unable to comply with the lifestyle guidelines described in this protocol

• Subjects who are inadequate for this study to participate judged by investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chonbuk National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samil Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samil Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02579356
• Other Study ID Numbers: SI-1307
• First Posted: Oct 19, 2015
• Last Update Posted: Oct 19, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Essential Hypertension; Telmisartan; Atorvastatin

Study Results

No Results Posted as of Oct 19, 2015