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About
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR capsules of Dr. Reddy's Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets)of Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fed conditions.
Full description
This study used a crossover design consisting of 2 treatments, 2 sequences and 2 periods. Study Period-I and IT were separated by a washout period of 14 days. Use of a crossover design is appropriate since it enables comparison of treatments within the same subject using intrasubject variability thus improving the precision of treatment comparisons. Also use of 14 days of washout period between successive drug administrations eliminates chances of residual drug being present at preceding period (i.e Period 1) to next period (i.e Period II).
Enrollment
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Inclusion criteria
Healthy human subjects within the age range of 18 to 45 years.
Non-smokers since at least six months.
Willingness to provide written informed consent to participate in the study.
Body-mass index of ≥18.5 kg/m2 and≤ 24.9 kglm2, with body weight not less than 50 kg.
Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening.
Normal 12-lead ECG or one with abnormality considered to be clinically insignificant.
Normal chest X-ray PA view.
Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
Female Subjects:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
62 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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