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NCT02789475 Clinical Trial

DP-R212 Pharmacokinetic Study

Hypertension Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02789475
Other study ID # DP-CTR-212-I-01
Secondary ID
Status Recruiting
Phase Phase 1
First received May 23, 2016
Last updated June 2, 2016
Start date May 2016
Est. completion date July 2016

Study information
Verified date May 2016
Source Alvogen Korea
Contact Chul woo Kim, Ph.D.
Phone 82-92-890-1168
Email cwkim1805@inha.ac.kr
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.

Recruitment information / eligibility
Status Recruiting
Enrollment 38
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria:

- BMI 18-29

- signed the informed consent form prior to the study participation

Exclusion Criteria:

- Clinically significant disease

- Previously donate whole blood within 60 days or component blood within 14 days

- Clinically significant allergic disease

- Taken IP in other trial within 90 days

- An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Amlodipine
Amlodipine administration
• Rosuvastatin
Rosuvastatin administration

Locations
Country Name City State
Korea, Republic of Inha university hospital Jung-gu Incheon

Sponsors (1)
Lead Sponsor Collaborator
Alvogen Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCt,ss of Amlodipine and Rosuvastatin 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr No
Primary Cmax,ss of Amlodipine and Rosuvastatin 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr No
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