Bioavailability of Prochlorperazine Suppositories, 25 mg

Padagis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Prochlorperazine suppositories, 25mg; Drug: Compazine® suppositories, 25mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992472

1670110293

Details and patient eligibility

About

The purpose of this study is to compare prochlorperazine plasma concentrations produced after administration of the test formulation with those produced after administration of a marketed reference product.

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

Exclusion criteria

• Positive test results for HIV or Hepatitis B or C
• History of allergy or sensitivity to Prochlorperazine or related drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Prochlorperazine suppositories, 25mg

Experimental group

Treatment:

Drug: Prochlorperazine suppositories, 25mg

Compazine® suppositories, 25mg

Active Comparator group

Treatment:

Drug: Compazine® suppositories, 25mg