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

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hypertension With Hyperlipidemia

Treatments: Drug: telmisartan/amlodipine and atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03461081

JLP-1610-101-DDI

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

Group I

Experimental group

Description:

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

Treatment:

Drug: telmisartan/amlodipine and atorvastatin

Group II

Experimental group

Description:

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

Treatment:

Drug: telmisartan/amlodipine and atorvastatin