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

A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study to Compare Omeprazole 40 mg DR Capsules Dr. Reddy's Laboratories Ltd.,With Prilosec® 40 mg Merck & Co.Inc., USA Under Fasting Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01170169

Enrollment

Registered

2010-07-27

Start date

2006-01-31

Completion date

2006-03-31

Last updated

2010-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed 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 44 healthy, adult, human subjects under fasting conditions.

Interventions

DRUGOmeprazole

Omeprazole Delayed Release Capsules 40 mg

DRUGPrilosec

Prilosec® 40 mg of Merck & Co.Inc.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on Cmax and AUC parameters	5 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026