Study of DWJ1351 in Healthy Male Volunteers

Phase 1

• Conditions: Healthy
• Interventions: Drug: DWJ1351; Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)

• Registration Number: NCT02665832
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-25
• Last Update Submitted: 2016-01-25
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BA	Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)	DWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)
AB	DWJ1351	Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351
AB	Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)	Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351
BA	DWJ1351	DWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)

Primary Outcome Measures

Name	Time	Method
AUC	0 - 144 hr
Cmax	0 - 144 hr