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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Allergy

Treatments: Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories); Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00947063

B043722

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

1

Experimental group

Description:

Promethazine HCl 50 mg Tablets (Sandoz, Inc)

Treatment:

Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc)

2

Active Comparator group

Description:

Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)

Treatment:

Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)