CClinicalTrials.gg
Status unknownNCT02665832Updated Jan 28, 2016

Study of DWJ1351 in Healthy Male Volunteers

A Phase 1 interventional study of DWJ1351 and Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) in Healthy, sponsored by Daewoong Pharmaceutical Co. LTD.. Status unknown. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    AB

    Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351

    Drug: DWJ1351 · Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)

  • Experimental
    BA

    DWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)

    Drug: DWJ1351 · Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)

Interventions

  • DrugDWJ1351
  • DrugCo-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)
06

What researchers measure

Primary outcomes

  1. AUC

    Time frame: 0 - 144 hr

  2. Cmax

    Time frame: 0 - 144 hr

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02665832
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Jan 28, 2016
Start date
Jan 2016
Primary completion
Jun 2016 (estimated)
Completion
Jun 2016 (estimated)
Last update
Jan 28, 2016

Study contacts

Sang-Joon Kim
Contact
sjkim050@daewoong.co.kr
+82 550 8708

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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