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

Phase 1

Completed

• Conditions: Hypertension With Hyperlipidemia
• Interventions: Drug: telmisartan/amlodipine and atorvastatin

• Registration Number: NCT03461081
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-07
• Primary Completion: 2017-07-12
• Study Completion: 2017-12-12
• Status Verified: 2018-03
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-08
• Study First Posted: 2018-03-09
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group II	telmisartan/amlodipine and atorvastatin	Period I: administration of atorvastatin for 4 days Period II: administration of telmisartan/amlodipine for 10 days then administration of telmisartan/amlodipine and atorvastatin for 4 days
Group I	telmisartan/amlodipine and atorvastatin	Period I: administration of telmisartan/Amlodipine for 10 days then administration of telmisartan/amlodipine and atorvastatin for 4 days Period II: atorvastatin for 4 days

Primary Outcome Measures

Name	Time	Method
AUCτ 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
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of