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

Phase 1CompletedNCT00947063

Sandoz36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Allergy

Interventions

Promethazine HCl 50 mg Tablets (Sandoz, Inc)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 12 days

Data from ClinicalTrials.gov

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