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Clinical Trial 38890

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San Antonio, TX 78209


Study Summary:

ICON Early Phase Services is conducting a research study for healthy adults ages 18-55 inclusive. This study is being done to test a new formulation of an approved pain medication.  The study drugs will be administered orally. 

Vital signs, ECGs, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study. 

Participants will complete:

  • 1 screening visit
  • 8 overnights (over 2 periods)
  • 1 follow-up call

To determine if you fully qualify, it will be necessary to obtain blood samples after a  10- hour fast.  You have the option of fasting for the screening appointment, or, you may return at a later date. You may need to provide medical records to participate in this study.  For more information, see below.



If you are able to answer “YES” to the following statements, you may qualify for this study.

 

  • I am a healthy ambulatory adult, meaning no significant medical conditions

 

  • I am between 18 and 55 years of age inclusive

 

  • My BMI is between 18.5 and 30.0 kg/m2  inclusive

 

  • I weigh at least 110 lbs.

 

  • I am a non-smoker and I have not used any type of tobacco product (including smoking cessation nicotine-containing products such as gum or patches) within the previous three months.  I agree not to smoke for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility.

 

  • I have not participated in any other trials involving investigational or marketed products within 30 days prior to the screening visit

 

  • If Female, I am not pregnant or breastfeeding   

 

  • If Female and capable of becoming pregnant, I have been using a medically accepted method of contraception as outlined below:

       at least 3 months prior to screening - oral contraceptives

       at least 1 month prior to screening -

       implantable device such as an implantable rod or intrauterine device OR

       hormonal contraceptives (patch, injectable or vaginal ring) OR

       a double barrier method

 

  • If Female and not capable of becoming pregnant, I have been postmenopausal for at least 2 years or I am surgically sterile (hysterectomy and/or bilateral oophorectomy)

 

  • I am able to communicate effectively in English with the study personnel

 

  • I do not have any active, acute or chronic diseases

 

  • I do not have a vegetarian or restricted diet (e.g., gluten-free)

 

  • I am able and willing to consume all contents of a standardized high calorie, high fat meal within 30 minutes  

 

  • I do not have a history of hypersensitivity symptoms from the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid, other nonsteroidal anti-inflammatory drugs (NSAIDs), or similar agents or components

 

  • I have not taken any naproxen/naproxen sodium, DPH HCl or diphenhydramine citrate, DPH HCl or diphenhydramine citrate-containing products, acetylsalicylic acid (ASA), ASA-containing products, acetaminophen, ibuprofen, any other NSAIDs (over-the counter/OTC or prescription) within 7 days prior to dosing or during the dosing periods

 

  • I agree to avoid taking any NSAID containing products, xanthines, antihistamines or caffeine­containing products (e.g. coffee, tea and chocolate) within 7 days prior to dosing and I agree to avoid consuming these products during the dosing periods

 

  • I have not used any over-the-counter or prescription medications, vitamins or herbal supplements (except acceptable forms of birth control) within 7 days prior to dosing, and, I agree not to use these products during the study

 

  • I have not recently had (past 30 days prior to screening) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or within 2 weeks after treatment

 

  • I have moderate (<40 g of alcohol regularly per day) alcohol consumption

 

  • I do not have a history of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse

 

  • I do not have a current or past history of controlled substance dependence

 

  • I do not have a history of alcoholism or drug abuse within 2 years prior to the screening visit

 

  • I have not had a loss of blood within 30 days, or 56 days, of 1st dose depending upon the blood volume

 

  • I agree to avoid excessive sports or sauna within 5 days before Day -1 and I agree to abstain from these activities during the study 

 

  • I have not had sun (or solarium) exposure beyond my usual activities

 

  • I do not have a history of gastrointestinal bleeding or perforation related to previous NSAID therapy, or active/recurrent peptic ulcer or hemorrhage

 

  • I do not have evidence or history of clinically significant hematological, renal, endocrine, pulmonary,  gastrointestinal,  cardiovascular, hepatic, psychiatric, neurologic diseases (including glaucoma or benign prostatic hypertrophy)  or malignancies or any other diseases or conditions

 

  • I do not have a previous medical history of gout or reduced uric acid excretion

 

  • I agree to abstain from  grapefruit/pomelos-containing food/beverages during the study

 

  • I agree to avoid the consumption of alcohol within 24 hours prior to dosing in the clinic. (NOTE: This will be verified on Day -1 of each dosing period.)


Qualified Participants May Receive:

Qualified participants may be compensated up to $2,725 for time and travel.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.