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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omeprazole

Omeprazole Delayed Release Capsules of Dr. Reddy's laboratories limited

Group Type EXPERIMENTAL

Omeprazole

Intervention Type DRUG

Omeprazole Delayed Release Capsules 40 mg

Prilosec

Prilosec® 40 mg of Merck \& Co.Inc.

Group Type ACTIVE_COMPARATOR

Prilosec

Intervention Type DRUG

Prilosec® 40 mg of Merck \& Co.Inc.

Interventions

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Omeprazole

Omeprazole Delayed Release Capsules 40 mg

Intervention Type DRUG

Prilosec

Prilosec® 40 mg of Merck \& Co.Inc.

Intervention Type DRUG

Other Intervention Names

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Prelosec 40 mg

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes