Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition

Launched by DR. REDDY'S LABORATORIES LIMITED · Jul 26, 2010

Keywords

ClinConnect Summary

This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr. Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules) (manufactured by Merck \& Co., Inc., USA) in 54 healthy, adult, human subjects under fed conditions.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Subjects who provided written informed consent.
• • Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.
• • Body mass index of ≥18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
• • Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).
• • Subjects with normal ECG, chest X-ray (PA view) and vital signs.
• • Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.