Overview

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

Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
0
Participant gender:
All
Summary
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fasting condition.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Omeprazole
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