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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01778075
First received: January 25, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER)
Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Plasma concentrations of acetaminophen (Period 1) [ Time Frame: Up to 48 hours following the administration of study drug on Day 1 of Period 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Plasma concentrations of acetaminophen (Period 2) [ Time Frame: Up to 48 hours following the administration of study drug on Day 1 of Period 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events as a measure of safety and tolerability [ Time Frame: Approximately 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: December 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment sequence AB
Treatment A: Newly developed Ultracet ER; Treatment B: Marketed Ultracet ER
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 BA
Treatment A: Newly developed Ultracet ER; Treatment B: Marketed Ultracet ER
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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778075

Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01778075     History of Changes
Other Study ID Numbers: CR100924, TRAMCTPAI1003
Study First Received: January 25, 2013
Last Updated: February 7, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Healthy
Ultracet extended release (ER)
Tramadol hydrochloride
Acetaminophen
Bioequivalence

Additional relevant MeSH terms:
Acetaminophen
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 28, 2014