Study of DWJ1351 in Healthy Male Volunteers

Healthy Clinical Trial

Official title:

A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02665832
• Other study ID #: DW_DWJ1351002
• Status: Not yet recruiting
• Phase: Phase 1
• First received: January 20, 2016
• Last updated: January 25, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Sang-Joon Kim
• Phone: +82 550 8708
• Email: sjkim050[@]daewoong.co.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy adult male subjects aged 19 to 50 years

• Subjects whose body weight = 55 kg and Body Mass Index(BMI) = 18.0 kg/m2 and = 27.0 kg/m2

• Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results

• Subject who provided written informed consent to participate in this study

Exclusion Criteria:

• Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs

• Subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, digestive system, reproductive system, neurology, psychology, ophthalmic and skin disease

• Subjects who had a serious clinical illness that can impact fate of drugs absorption

• Subject who shows vital signs with the number of systolic blood pressure of =150 mmHg or =100 mmHg, and the number of diastolic blood pressure of =100mmHg or =66mmHg

• Subject who have experienced drug abuse

• Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month)

• Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DWJ1351

• Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC		0 - 144 hr	No
Primary	Cmax		0 - 144 hr	No