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

Dr.Reddy's Laboratories

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Prilosec; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01170169

7566/05-06

Details and patient eligibility

About

This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fasting 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 44 healthy, adult, human subjects under fasting conditions.

Enrollment: 44 patients

Sex: All

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.

Test product, dose, mode of administration and batch number

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Omeprazole

Experimental group

Description:

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

Treatment:

Drug: Omeprazole

Prilosec

Active Comparator group

Description:

Prilosec® 40 mg of Merck \& Co.Inc.

Treatment:

Drug: Prilosec