Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers

Hypertension With Hyperlipidemia Clinical Trial

Official title:

An Open-label, Randomized, Two-sequence, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461081
• Other study ID #: JLP-1610-101-DDI
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2018
• Last updated: March 8, 2018
• Start date: May 7, 2017
• Est. completion date: December 12, 2017

Study information

• Verified date: March 2018
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

study to evaluate drug-drug interaction following oral administration of telmisartan/amlodipine and atorvastatin in healthy adult volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 12, 2017
• Est. primary completion date: July 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• 19~55 years healthy male

• The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2

• Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion Criteria:

• Subjects who are allergic to investigational drug.

• Subjects who have a medical history which can affect the clinical trial.

• Hypertension(Systolic BP = 150mmHG or Diastolic BP = 100mmHg), Hypotension(Systolic BP = 100mmHg or Diastolic BP = 70mmHg)

• Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension With Hyperlipidemia

Intervention

Drug:
• telmisartan/amlodipine and atorvastatin
Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin		Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours
Primary	Css,max of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin		Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours