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Bioavailability of Prochlorperazine Suppositories, 25 mg

Bioavailability of Prochlorperazine Suppositories, 25 mg

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00992472
Enrollment
42
Registered
2009-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGProchlorperazine suppositories, 25mg
DRUGCompazine® suppositories, 25mg

Sponsors

Padagis LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Bioequivalence according to US FDA guidelines

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026