The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: Rosuvastatin; Drug: Rosuvastatin and Telmisartan/Amlodipine; Drug: Telmisartan/Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02387619

JLP-1401-P1-DI

Details and patient eligibility

About

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

Full description

A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

Enrollment: 41 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 19~55 years healthy male
• Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 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 ≤ 65mmHg)
• 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)

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41 participants in 4 patient groups

Group 1 of part 1

Experimental group

Description:

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2

Treatment:

Drug: Rosuvastatin and Telmisartan/Amlodipine

Drug: Rosuvastatin

Group 2 of part 1

Experimental group

Description:

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2

Treatment:

Drug: Telmisartan/Amlodipine

Drug: Rosuvastatin and Telmisartan/Amlodipine

Group 1 of part 2

Experimental group

Description:

Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2

Treatment:

Drug: Rosuvastatin and Telmisartan/Amlodipine

Drug: Rosuvastatin

Group 2 of part 2

Experimental group

Description:

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2

Treatment:

Drug: Telmisartan/Amlodipine

Drug: Rosuvastatin and Telmisartan/Amlodipine