To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Allergy
• Interventions: Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories); Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc)

• Registration Number: NCT00947063
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)	Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)
1	Promethazine HCl 50 mg Tablets (Sandoz, Inc)	Promethazine HCl 50 mg Tablets (Sandoz, Inc)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	12 days