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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Co-administration of Olmetec and Crestor; Drug: Olostar Tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02561884

DW_DWJ1276006

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

58 participants in 2 patient groups

AB

Experimental group

Description:

Olostar Tab. followed by Olmetec and Crestor

Treatment:

Drug: Olostar Tab.

Drug: Co-administration of Olmetec and Crestor

BA

Experimental group

Description:

Olmetec and Crestor followed by Olostar Tab.

Treatment:

Drug: Olostar Tab.

Drug: Co-administration of Olmetec and Crestor