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

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Olmesartan Medoxomil; Rosuvastatin Calcium

Criteria

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