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A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition

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ClinicalTrials.gov Identifier: NCT01778075
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

January 25, 2013
January 29, 2013
February 10, 2014
December 2012
February 2013   (Final data collection date for primary outcome measure)
  • Plasma concentrations of racemic tramadol (Period 1) [ Time Frame: Up to 48 hours following the administration of study drug on Day 1 of Period 1 ]
  • Plasma concentrations of acetaminophen (Period 1) [ Time Frame: Up to 48 hours following the administration of study drug on Day 1 of Period 1 ]
  • Plasma concentrations of racemic tradamdol (Period 2) [ Time Frame: Up to 48 hours following the administration of study drug on Day 1 of Period 2 ]
  • Plasma concentrations of acetaminophen (Period 2) [ Time Frame: Up to 48 hours following the administration of study drug on Day 1 of Period 2 ]
Same as current
Complete list of historical versions of study NCT01778075 on ClinicalTrials.gov Archive Site
Incidence of adverse events as a measure of safety and tolerability [ Time Frame: Approximately 5 weeks ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition
A Single Dose, Open-Label, Randomized, Two-Way Crossover Pivotal Study to Assess the Bioequivalence of a New ULTRACET ER Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition
The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current marketed ULTRACET ER tablet, in healthy participants under fasted condition.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER)
    Single oral dose of newly developed ULTRACET ER, (Tramadol HCl/Acetaminophen 75/650 mg), administered under fasted condition.
  • Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)
    Single oral dose of marketed ULTRACET ER, (Tramadol HCl/Acetaminophen 75/650 mg), administered under fasted condition.
  • Experimental: Treatment sequence AB
    Treatment A: Newly developed Ultracet ER; Treatment B: Marketed Ultracet ER
    Interventions:
    • Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER)
    • Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)
  • Experimental: Treatment sequence BA
    Treatment A: Newly developed Ultracet ER; Treatment B: Marketed Ultracet ER
    Interventions:
    • Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER)
    • Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
Same as current
February 2013
February 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate
  • Must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
  • Body mass index (weight [kg]/height2 [m]2) between 18.5 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
  • Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic
  • A 12-lead electrocardiogram (ECG) consistent with normal cardiac function, including sinus rhythm, pulse rate between 45 and 90 bpm, QTc interval <= 450 ms, QRS interval of <110 ms, PR interval <200 ms, and morphology consistent with healthy cardiac function

Exclusion Criteria:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic (blood) disease, coagulation disorders (including any abnormal bleeding), lipid abnormalities, significant lung disease (including bronchospastic respiratory disease), diabetes mellitus, kidney or liver insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
  • Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening (or at admission to the study center) as deemed appropriate by the investigator
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
  • History of, or reason to believe a participant has a history of, drug or alcohol abuse within the past 5 years
Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01778075
CR100924
TRAMCTPAI1003 ( Other Identifier: Janssen Korea, Ltd., Korea )
No
Not Provided
Not Provided
Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
Not Provided
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP