A Phase 1 interventional study of Pantoprazole Sodium in Fasting, sponsored by Dr. Reddy's Laboratories Limited. Completed at 1 site in India. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-26.
Sponsored by Dr. Reddy's Laboratories Limited · Phase 1, Interventional, and Treatment
To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets (Wyeth Laboratories, USA) in 42 (+ 4 standby) healthy, adult, human subjects under fasting conditions.
This is a Open label, balanced, randomized two-treatment, two-period,two-sequence, crossover bioequivalence study with at least 07 days washout period between each drug administration under fasting conditions.42 (+4 standby) healthy, adult, human subjects were enrolled. A single oral dose of40 mg of pantoprazole delayed release tablet will be administered along with 240 mL of drinking water after an overnight fast of at least 10 hours in each period.
Dr. Reddy's Laboratories Limited is the lead sponsor of 220 studies on the registry; 2 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
If subject is a female volunteer and
Exclusion Criteria:
Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddys Laboratories Limited
Drug: Pantoprazole Sodium
Protonix 40 mg DR Tablets of Wyeth Laboratories
Drug: Pantoprazole Sodium
Pantoprazole Sodium DR Tablets 40 mg
Also known as: Protonix DR Tablets 40 mg
Bioequivalence on Cmax and AUC parameters
Time frame: 2 months
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dr. Reddy's Laboratories Limited