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 is currently recruiting participants.
Verified February 2013 by Janssen Korea, Ltd., Korea
Sponsor:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01778075
First received: January 25, 2013
Last updated: February 21, 2013
Last verified: February 2013
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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 ]
| Estimated Enrollment: | 56 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778075
Contacts
| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Locations
| Korea, Republic of | |
| Recruiting | |
| 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 21, 2013 |
| 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 Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Narcotics Central Nervous System Depressants Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 16, 2013