The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

Hypertension Clinical Trial

Official title:

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387619
• Other study ID #: JLP-1401-P1-DI
• Status: Completed
• Phase: Phase 1
• First received: March 9, 2015
• Last updated: June 23, 2016
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: March 2015
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Drug:
• Rosuvastatin
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days
• Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
• Rosuvastatin and Telmisartan/Amlodipine
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System	Seoul	Seodaemun-gu

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,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine		72hours, 144hours	No
Secondary	AUClast,ss of Rosuvastatin		72hours	No
Secondary	AUCinf,ss of Rosuvastatin		72hours	No
Secondary	Tmax,ss of Rosuvastatin		72hours	No
Secondary	t1/2 of Rosuvastatin		72hours	No
Secondary	AUClast,ss of Telmisartan, Amlodipine		144hours	No
Secondary	AUCinf,ss of Telmisartan, Amlodipine		144hours	No
Secondary	Tmax,ss of Telmisartan, Amlodipine		144hours	No
Secondary	t1/2 of Telmisartan, Amlodipine		144hours	No