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

Dr.Reddy's Laboratories

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Device: Prilosec® 40 mg

Drug: Omeprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01170182

7577/05-06

Details and patient eligibility

About

This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fed condition.

Full description

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.

Enrollment

54 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.