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NCT02561884 Clinical Trial

A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study on a Olostar Tab Versus Two Co-administered Reference Products Olmesartan Medoxomil and Rosuvastatin Calcium in Healthy Volunteers

Healthy Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02561884
Other study ID # DW_DWJ1276006
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received September 24, 2015
Last updated September 25, 2015
Start date October 2015
Est. completion date October 2015

Study information
Verified date September 2015
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug Control
Study type Interventional

Clinical Trial Summary

To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 58
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- BMI = 18.5 and = 30.0 kg/m2.

- No clinically significant findings in a 12-lead electrocardiogram (ECG)

- Age 18-60 years at screening

Exclusion Criteria:

- History of severe allergy or allergic reactions to the IMPs or related drugs

- History of serious clinical illness that can impact fate of drugs including major surgery

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Olostar Tab.

• Co-administration of Olmetec and Crestor

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 0~72hr No
Primary Cmax 0~72hr No
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