Delving into the Latest Updates on Tramadol Hydrochloride/Acetaminophen with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Paracetamol and Tramadol Hydrochloride, Tramadol Hydrochloride Paracetamol, Tramadol/Paracetamol

+ [15]

Target

COXs x μ opioid receptor

Action

inhibitors, agonists

Mechanism

COX inhibitors(Cyclooxygenases inhibitors), μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

PainCancer PainAcute Pain

Inactive Indication

Ankle InjuriesChronic PainLow Back Pain+ [3]

Originator Organization

Ortho-McNeil Pharmaceutical LLC

Active Organization

Xian-Janssen Pharmaceutical Ltd.Aspen Pharmacare Australia Pty Ltd.Janssen Pharmaceutical KK

Inactive Organization

Janssen Pharmaceuticals, Inc.

Janssen Korea Ltd.Johnson & Johnson Pharmaceutical Research & Development LLC

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (15 Aug 2001),

Acute Pain

Regulation-

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Structure/Sequence

Molecular FormulaC24H35ClN2O4

InChIKeyUFLWHLMSTCRAJP-WUTOMRCLSA-N

CAS Registry147630-10-2

主要研究目的研究空腹/餐后状态下单次口服氨酚曲马多片（规格：盐酸曲马多37.5mg和对乙酰氨基酚325mg，宜昌人福药业有限责任公司生产）与氨酚曲马多片（商品名：ULTRACET ，规格：盐酸曲马多37.5mg和对乙酰氨基酚325mg；Janssen Ortho LLC生产）在中国健康成年受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的研究受试制剂氨酚曲马多片（盐酸曲马多37.5mg和对乙酰氨基酚325mg）和参比制剂（商品名：ULTRACET ，盐酸曲马多37.5mg和对乙酰氨基酚325mg）在中国健康成年受试者体内的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of a single oral dose of tramadol acetaminophen tablets (specifications: 37.5 mg tramadol hydrochloride and 325 mg acetaminophen, produced by Yichang Renfu Pharmaceutical Co., Ltd.) and tramadol acetaminophen tablets (trade name: ULTRACET, specifications: 37.5 mg tramadol hydrochloride and 325 mg acetaminophen; produced by Janssen Ortho LLC) in healthy Chinese adult subjects in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in the fasting/fed state. Secondary study objectives To study the safety of the test preparation tramadol acetaminophen tablets (37.5 mg tramadol hydrochloride and 325 mg acetaminophen) and the reference preparation (trade name: ULTRACET, 37.5 mg tramadol hydrochloride and 325 mg acetaminophen) in healthy Chinese adult subjects.

Start Date19 Nov 2021

Sponsor / Collaborator

Yichang Humanwell Pharmaceuticals Co., Ltd.

CTR20212138

/ CompletedNot Applicable

单中心、随机、开放、单剂量、双周期交叉试验设计评价中国健康受试者空腹和餐后口服氨酚曲马多片的生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-period crossover study to evaluate the bioequivalence of fasting and fed oral tramadol tablets in Chinese healthy subjects

主要目的：以Janssen Ortho, LLC.公司生产的氨酚曲马多片(商品名：ULTRACET®，规格：盐酸曲马多37.5mg，对乙酰氨基酚325mg)为参比制剂，以陕西九州制药有限责任公司研究生产的氨酚曲马多片(规格：盐酸曲马多37.5mg，对乙酰氨基酚325mg)为受试制剂，通过单中心、随机、开放、单剂量、双周期、交叉试验设计评价两制剂的生物等效性。次要目的：评价受试制剂和参比制剂在中国健康成年受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the two preparations by using a single-center, randomized, open, single-dose, two-period, crossover design, using tramadol acetaminophen tablets (trade name: ULTRACET®, specifications: tramadol hydrochloride 37.5 mg, acetaminophen 325 mg) produced by Janssen Ortho, LLC. as the reference preparation and tramadol acetaminophen tablets (specifications: tramadol hydrochloride 37.5 mg, acetaminophen 325 mg) produced by Shaanxi Jiuzhou Pharmaceutical Co., Ltd. as the test preparation. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy adult subjects in China.

Start Date21 Aug 2021

Sponsor / Collaborator

Shaanxi Jiuzhou (Group) Pharmaceutical Industry Co.

100 Clinical Results associated with Tramadol Hydrochloride/Acetaminophen

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100 Translational Medicine associated with Tramadol Hydrochloride/Acetaminophen

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100 Patents (Medical) associated with Tramadol Hydrochloride/Acetaminophen

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25

Literatures (Medical) associated with Tramadol Hydrochloride/Acetaminophen

01 Aug 2023·Plastic Surgery

Pain Medication Prescribing Patterns in Augmentation Mammoplasty

Article

Author: Winter, Jessica ; Islur, Avi ; Peters, Blair R. ; Cruise, Braden

Background: The rate of opioid prescribing after low-risk surgical procedures has increased over the past decade, and surgeons are responsible for prescribing approximately one-third of all opioid medications. There is additional supporting evidence that patients only consume about half of the opioids prescribed to them after outpatient plastic surgery. Currently, there is no literature to provide surgeons with reference ranges for how much opioid medication will adequately provide analgesia for patients after undergoing bilateral breast augmentation (BBA) surgery. Objective: To quantify the amount of opioid medication required to adequately control pain for patients after undergoing BBA and use these data to provide recommendations on opioid prescribing practices. Methods: Cross-sectional prospective data were obtained through a take-home medication and pain tracking questionnaire for 56 patients after they underwent either subpectoral or subglandular BBA. Patients documented their pain scores on a 0 to 10 analogue scale and documented the type and amount of pain medication they took for a 7-day period. Results: Our study demonstrated that patients in the subglandular BBA group required an average of either 25 ± 1.2 Tylenol #3 or 19.3 ± 2.3 Tramacet tablets, and the subpectoral group required 27.7 ± 1.7 Tylenol #3 or 25.6 ± 0.9 Tramacet tablets over a 7-day period. There was no statistically significant difference between the 2 surgical groups. Conclusion: We propose a reference range of medication required on average for patients undergoing BBA to obtain adequate pain control in the initial postoperative period that falls within the most recent Canadian guidelines for safe opioid prescribing practices.

01 Jan 2022·Translational and Clinical Pharmacology

Comparative pharmacokinetics between two tablets of tramadol 37.5 mg/acetaminophen 325 mg and one tablet of tramadol 75 mg/acetaminophen 650 mg for extended-release fixed-dose combination

Article

Author: Jang, In-Jin ; Kim, JaeWoo ; Hong, Jang Hee ; Kim, Hyun Chul ; Yoon, Deok Yong ; Lee, SeungHwan

An extended-release (ER) fixed-dose combination (FDC) of tramadol 37.5 mg/acetaminophen 325 mg was developed due to the demand for varying dosages. This study aimed to evaluate the pharmacokinetics (PKs) for two tablets of the new developed tramadol 37.5 mg/acetaminophen 325 mg ER FDC (DW-0920, Wontran Semi ER^®) as test formulation compared to one tablet of the tramadol 75 mg/acetaminophen 650 mg ER FDC (DW-0919, Wontran ER^®) as reference formulation. A randomized, open-label, 2-way crossover study was conducted in 30 healthy subjects. Subjects were orally administered one of 2 formulations followed by an alternate formulation with a 7-day washout period. Blood samples were collected up to 36 hours post-dose. Plasma concentrations of tramadol and acetaminophen were determined using a validated high-performance liquid chromatography with tandem mass spectrometric method. The geometric mean ratios (GMRs) and their 90% confidence intervals (90% CIs) of test formulation to reference formulation were calculated for the maximum plasma concentration (C_max) and the area under the plasma concentration-time curve from zero to the last measurable time point (AUC_last). The PK profiles of 2 formulations were comparable. The GMRs (90% CI) of C_max and AUC_last for tramadol were 1.086 (1.047-1.127) and 1.008 (0.975-1.042), respectively. The corresponding values for acetaminophen were 0.956 (0.897-1.019) and 0.986 (0.961-1.011), respectively. All the values were within the bioequivalence range of 0.80-1.25. Two tablets of DW-0920 were comparable to one tablet of DW-0919. The DW-0920 may be used for optimal pharmacotherapy for pain control with a lower dose.Trial RegistrationClinicalTrials.gov Identifier: NCT01606059.

01 Jan 2021·Journal of Orthopaedic ScienceQ4 · MEDICINE

Impact of background factors on outcomes of pharmacological therapy for chronic low back pain: A nationwide multicenter prospective study

Q4 · MEDICINE

Article

Author: Imagama, Shiro ; Inoue, Gen ; Yamada, Hiroshi ; Kaito, Takashi ; Nishida, Kotaro ; Yamazaki, Masashi ; Ohtori, Seiji ; Shintani, Ayumi ; Murakami, Hideki ; Kawakami, Mamoru ; Taguchi, Toshihiko ; Takura, Tomoyuki ; Matsuyama, Yukihiro ; Miyakoshi, Naohisa ; Yonenobu, Kazuo ; Taneichi, Hiroshi ; Yamashita, Toshihiko ; Haro, Hirotaka ; Yoshida, Munehito ; Iwasaki, Motoki ; Ito, Manabu ; Takahashi, Kazuhisa ; Mochida, Joji ; Kabata, Daijiro

BACKGROUNDChronic low back pain (CLBP) is a major cause of chronic pain with nociceptive, neuropathic or both pain components, and a leading cause of disability. The objectives of this study were to determine the impact of background factors including previous use of drugs on outcomes of pharmacological therapy for CLBP in a nationwide multicenter prospective study.METHODSThe subjects were 474 patients (male: 41.9%, median age: 73.0) with CLBP. Background factors that could influence outcomes after pharmacological treatment for 6 months were examined: age, gender, body mass index (BMI), duration of CLBP, osteoporosis, history of spinal surgery, history of malignant tumor, smoking habit, employment status (yes or no), exercise habit (frequency), number of live-in family members, having something to do for pleasure, Center for Epidemiologic Studies depression scale (CES-D) score, and medication at baseline. Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) for LBP, JOA Back Pain Evaluation Questionnaire (JOABPEQ), Roland-Morris Disability Questionnaire (RDQ), Short-form 8-item health survey (SF-8), and EQ-5D were used for evaluation at baseline and after 6 months. Multivariate linear regression models were used in statistical analysis.RESULTSDrugs for neuropathic pain at baseline (p < 0.001), Tramacet® at baseline (p < 0.05), weak opioids at baseline (p < 0.05), older age (p < 0.001), long disease duration (p < 0.005), history of spinal surgery (p < 0.001), and smoking habit (p < 0.001) had significant negative effects on outcomes. Employment (p < 0.05), exercise habit (p < 0.05), and CED-D at baseline (p < 0.001) had positive effects on outcomes.CONCLUSIONSThis is the first study to identify significant prognostic factors for outcomes of pharmacological treatment of CLBP. The neuropathic pain component of CLBP at baseline is a major significant negative factor for most outcomes involving improved pain, activities of daily life, and quality of life. Treatment strategies developed with consideration of these factors may be advantageous for recovery from CLBP.

100 Deals associated with Tramadol Hydrochloride/Acetaminophen

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	N02AJ13	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pain	Australia	Aspen Pharmacare Australia Pty Ltd.	19 Mar 2012
Cancer Pain	Japan	Janssen Pharmaceutical KK	22 Apr 2011
Acute Pain	China	Xian-Janssen Pharmaceutical Ltd.	01 Apr 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pain, Postoperative	Phase 2	-	Janssen Korea Ltd.	01 Nov 2009
Low Back Pain	Phase 2	-	Janssen Korea Ltd.	01 May 2009
Chronic Pain	Phase 2	Japan	Janssen Pharmaceuticals, Inc.	01 May 2008
Ankle Injuries	Phase 2	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 2003
Musculoskeletal Pain	Phase 2	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 2003
Sprains and Strains	Phase 2	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Dec 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCO_IOF_ESCEO2018	Not Applicable	Osteoarthritis, Knee	48	Tramadol/Acetaminophen	jltwphfcgy(tjkaonqfgj) = adpfaffijv mbbrcuivrn (auxptrtuqx ) View more	Positive	27 Jul 2018
				NSAID (Naproxen 500mg)	jltwphfcgy(tjkaonqfgj) = pxesnleyop mbbrcuivrn (auxptrtuqx ) View more
NCT02389361 (CTgov)	Phase 4	Hernia, Inguinal \| Pain, Postoperative	51	Zaldiar (Group Z)	dkvjurxffg(eizhzikuua) = drappcoiis rffasvgyqo (vvagbzyjsb, yblisvpbwr - pzqkkkhmaj) View more	-	13 Aug 2015
				Paracetamol-Tramadol (Group PT)	dkvjurxffg(eizhzikuua) = ztngoypelb rffasvgyqo (vvagbzyjsb, ticiqrketu - dblnlanurm) View more
WCO_IOF_ESCEO2015	Phase 3	Musculoskeletal Pain	52	Tramadol-Diclofenac	mfkucqmjuk(kejmbzuqvw) = nausea, vomiting, epigastric pain, gastritis shosndnbhv (ehjhumlulr )	Positive	17 Apr 2015
				Tramadol-Paracetamol
NCT01843660 (CTgov)	Phase 4	Low Back Pain \| Shoulder Pain \| Acute Pain \| Neck Pain	1,059	Tramadol HCl-Paracetamol	grwmtwwvnd(akrqwxzjft) = fuuobtkwuf ydoamqomle (qsutjthcvp, dtwfywosvb - fafcaibbjt) View more	-	26 Aug 2013
NCT00635349 (CTgov)	Phase 4	Osteoarthritis, Knee	143	Tramadol Hydrochloride Plus Acetaminophen+aceclofenac+meloxicam	fjcrijyouk(qrmkdqpdxv) = zdrcypdorc palmdoezbf (lhbuqtcwpe, rpuvqhermj - pkyuisganh) View more	-	24 Jun 2013
NCT01814878 (CTgov)	Phase 3	Pain, Postoperative	320	Tramadol HCl/Acetaminophen IR	dshrxlvlvr(qtasyojvwu) = lqenheuvul fudmetyyty (zlawmwmjzn, ajapaxpeay - csdrgfhnjy) View more	-	20 Jun 2013
NCT00736957 (CTgov)	Phase 3	Chronic Pain	219	Tramadol Hydrochloride+Acetaminophen+JNS013	dyqdejorjx(kasyvcnesj) = hbjvpjmkzp wdkgyczcft (ggmnvsdlvw, vlfxvuyeyv - fadbisxqxc) View more	-	20 Jun 2013
NCT01728246 (CTgov)	Phase 4	Chronic osteoarthritis	473	Tramadol/Paracetamol (APAP) (Tramadol/Paracetamol (APAP))	trytddcezi(dxkehoyjda) = xzddirwvcp jisfbhctri (keitaloofe, afgtoyzlng - albczondxv) View more	-	14 Jan 2013
				Non-Tramadol/APAP (Non-Tramadol/APAP)	trytddcezi(dxkehoyjda) = hosiggvqow jisfbhctri (keitaloofe, eeejcojxhx - oyjjwabzcg) View more
EULAR2006	Not Applicable	Chronic Pain	237	Tramadol/paracetamol 37.5 mg/325 mg	(hfdmztgapp) = zxlrvejhtb sgbtzctidz (zmqjepkftz ) View more	-	21 Jun 2006
				Codeine/paracetamol 30 mg/500 mg	(hfdmztgapp) = ejtnzaurqh sgbtzctidz (zmqjepkftz ) View more
Pubmed \| Headache	Not Applicable	Acute migraine	305	Tramadol/APAP	iagnainsqk(waggvskpmx) = mohzeumygp rjqbcifwkw (otrdvegxax ) View more	-	01 Nov 2005
				Placebo	iagnainsqk(waggvskpmx) = ivgzxmnjwu rjqbcifwkw (otrdvegxax ) View more