A Phase 1 interventional study of Promethazine HCl 50 mg Tablets (Sandoz, Inc) and Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) in Allergy, sponsored by Sandoz. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-28.
Sponsored by Sandoz · Phase 1, Interventional, and Treatment
To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions.
Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Promethazine HCl 50 mg Tablets (Sandoz, Inc)
Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc)
Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)
Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)
Bioequivalence based on AUC and Cmax
Time frame: 12 days
No study locations are listed for this record.
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Sandoz