Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions

Dr. Reddy's Laboratories Limited44 enrolled

Overview

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

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 44 healthy, adult, human subjects under fasting conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

OmeprazoleDRUG

Omeprazole Delayed Release Capsules 40 mg

PrilosecDRUG

Prilosec® 40 mg of Merck \& Co.Inc.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. Test product, dose, mode of administration and batch number

Outcomes

Primary Outcomes

Bioequivalence based on Cmax and AUC parameters

Time frame: 5 months

Data from ClinicalTrials.gov

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