To Demonstrate the Relative Bioavailability Study of Prom... | NCT00947063

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

NCT00947063

Sponsor

Sandoz

Status

Completed

Last Update Posted

Mar 28, 2017Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

Allergy

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Aug 2004Actual

Completion Date

Aug 2004Actual

First Submitted Date

Jul 24, 2009

First Submission Date that Met QC Criteria

Jul 24, 2009

First Posted Date

Jul 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2017

Last Update Posted Date

Mar 28, 2017Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Promethazine HCl 50 mg Tablets (Sandoz, Inc)	Drug		1
Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)

Measure	Description	Time Frame
Bioequivalence based on AUC and Cmax		12 days

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irwin Plisco, M.D.	Cetero Research, San Antonio	Principal Investigator

Locations

Not provided

ID	Term
D006967	Hypersensitivity

ID	Term
D007154	Immune System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D004155	Diphenhydramine
D011398	Promethazine

Ancestor Terms

ID	Term
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals
D001559	Benzhydryl Compounds

Browse Leaves

Not provided

Browse Branches

Not provided