NCT00947063

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

March 28, 2017

Status Verified

July 1, 2009

Enrollment Period

1 month

First QC Date

July 24, 2009

Last Update Submit

March 27, 2017

Conditions

Allergy

Keywords

Antihistamine

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    12 days

Study Arms (2)

1

EXPERIMENTAL

Promethazine HCl 50 mg Tablets (Sandoz, Inc)

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

2

ACTIVE COMPARATOR

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

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

Interventions

Promethazine HCl 50 mg Tablets (Sandoz, Inc)DRUG
1
Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)DRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypersensitivity

Interventions

DiphenhydraminePromethazine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

EthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPropylaminesPhenothiazinesSulfur CompoundsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Irwin Plisco, M.D.

    Cetero Research, San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

July 1, 2004

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

March 28, 2017

Record last verified: 2009-07