Bioavailability Study of Tramadol/APAP Tablets Under Fed... | NCT00652821

Studies
Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions

NCT00652821

Sponsor

Par Pharmaceutical, Inc.

Status

Completed

Last Update Posted

Sep 26, 2017Actual

Enrollment

22Actual

Phase

Phase 1

Conditions

To Determine Bioequivalence Under Fed Conditions

Interventions

Tramadol/ APAP
Ultracet

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

Sep 2017

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

May 2002

Primary Completion Date

Aug 2002Actual

Completion Date

Aug 2002Actual

First Submitted Date

Apr 1, 2008

First Submission Date that Met QC Criteria

Apr 1, 2008

First Posted Date

Apr 4, 2008Estimated

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

Sep 22, 2017

Last Update Posted Date

Sep 26, 2017Actual

Name	Class
AAI Clinic	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Subjects received Kali product under fed condition	Drug: Tramadol/ APAP
B	Active Comparator	Subjects received Ortho-Mcneil product under fed conditions	Drug: Ultracet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tramadol/ APAP	Drug	Tablets 37.5mg /325mg	A	Ultracet

Measure	Description	Time Frame
Rate and Extent of Absorption		24 Hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Males and females between 18 and 45 years of age inclusive
Informed of the nature of the study and given written informed consent.
Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100lbs.

Exclusion Criteria:

Hypersensitivity to Tramadol/ Acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures.
Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
Recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism.
Donation of greater than 500mL of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
Received an investigational drug within the 4 weeks prior to study dosing.
Currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing.
This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician.
Tobacco use(>5 cigarettes per day)in the 3 months prior to study dosing.
If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods.
Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed.
Medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D052456	Hypoalphalipoproteinemias
D007009	Hypolipoproteinemias
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

ID	Term
D014147	Tramadol
D000082	Acetaminophen
C478659	Ultracet