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Last Updated: December 1, 2023


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505(b)(2) Clinical Trials for Liquid E-z-paque

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00262145 ↗ Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption Completed NatureGen Phase 1 2005-10-01 Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by the intestinal mucosa). There has been some study of the ability of these products to reduce the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol levels in chronic studies. The purpose of the present study is to objectively determine if one cup of "tea" made from a combination of three types of tea leaves (mulberry, black and green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea. Research Design - The study will consist of a double blind, placebo controlled crossover study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon. On one of the test days the subjects (randomly) will concurrently consume the active preparation, a tea containing extracts of the three types of tea leave described above plus the meal, and on the other test day they will consume the meal with a liquid placebo preparation (warm water, sugar and food coloring). Subjects will provide a breath sample before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate malabsorption will be determined by the hydrogen concentration in the breath samples and fat malabsorption by the concentration of 13-CO2 in the breath samples. Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption and a low 13-CO2 indicates lipid malabsorption. Objective evidence that the tea leaf extract actually induces carbohydrate and/or fat malabsorption could provide the basis for further studies.
New Dosage NCT00858936 ↗ Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery Terminated Mallinckrodt Phase 2 2009-05-01 This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially reduce the damage done to the heart during surgery. This study has 2 parts. Part 1 will first test 36 subjects at different doses (amount) of the study drug. There will be 6 different groups of 6 subjects each that will receive the study drug or a placebo. A placebo is a substance that will be prepared to look like the study drug but will contain no active ingredients. In Part 1, five subjects from each group will receive study drug (IK-1001) and one will receive a placebo. This first part of this study is also a dose (amount) escalation. This means that each group will be receiving a different dose of the study drug. The first group will receive the lowest dose, the second group will receive a slightly higher dose, and the third group a slightly higher dose until all six groups has been tested. You can not choose which group you will be in but prior to starting each new dose level, the data (information) from the previous dose level will have been reviewed by a group of qualified individuals to determine if it is safe to proceed to the next highest dose level. Part 2 will expand the study and will treat at least 158 (and up to 632) more subjects at a dose level that has been deemed safe from information collected from Part 1. Subjects in Part 2 of the study will have a 1 in 2 (50%) chance of receiving the study drug or placebo. Whether the subject gets study drug or the placebo will be randomly assigned (like the toss of a coin). The study drug or placebo will be given as an intravenous infusion (into the vein) for six hours while the subject is having their CABG surgery. The subjects will be followed up for 6 months after their CABG surgery.
OTC NCT00894634 ↗ Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2009-03-21 The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs.
New Formulation NCT01267201 ↗ A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form Completed Pfizer Phase 1 2010-11-01 A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.
New Dosage NCT01323010 ↗ Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes Completed Fundação de Amparo à Pesquisa do Estado de São Paulo N/A 2011-09-01 Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Liquid E-z-paque

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000140 ↗ The Silicone Study Completed National Eye Institute (NEI) Phase 3 1985-09-01 To compare, through a randomized, multicenter surgical trial, the postoperative tamponade effectiveness of intraocular silicone oil with that of an intraocular long-acting gas (initially sulfur hexafluoride [SF 6 ], later perfluoropropane [C 3 F 8 ]) for the management of retinal detachment complicated by proliferative vitreoretinopathy (PVR), using vitrectomy and associated techniques. To evaluate the ocular complications that result from the use of silicone oil and gas.
NCT00000302 ↗ Study Comparing Liquid and Tablet Buprenorphine Formulations - 5 Completed National Institute on Drug Abuse (NIDA) Phase 3 1969-12-31 The purpose of this study is to compare liquid and tablet buprenorphine formulations.
NCT00000320 ↗ Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1 Completed National Institute on Drug Abuse (NIDA) Phase 1/Phase 2 1997-10-01 The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."
NCT00000341 ↗ Evaluation of Liquid vs. Tablet Buprenorphine - 6 Completed National Institute on Drug Abuse (NIDA) Phase 2 1996-08-01 The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.
NCT00000865 ↗ The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To assess the steady state pharmacokinetic features, tolerance, and safety of orally administered 1592U89, given alone or in combination with other antiretroviral medications, in HIV infected infants and children. To establish doses of 1592U89 appropriate for future pediatric Phase II/III clinical trials. On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent for treatment of HIV infection in children, either as an alternative to currently employed agents, or in combination therapy regimens. A liquid formulation of the drug is available; thus concurrent development of 1592U89 for children and adults is possible.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Liquid E-z-paque

Condition Name

Condition Name for Liquid E-z-paque
Intervention Trials
Healthy 74
Breast Cancer 25
Healthy Volunteers 24
Obesity 23
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Condition MeSH

Condition MeSH for Liquid E-z-paque
Intervention Trials
Diabetes Mellitus 48
Infections 45
Infection 40
Diabetes Mellitus, Type 2 35
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Clinical Trial Locations for Liquid E-z-paque

Trials by Country

Trials by Country for Liquid E-z-paque
Location Trials
Italy 94
Germany 93
Spain 79
France 79
Brazil 58
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Trials by US State

Trials by US State for Liquid E-z-paque
Location Trials
California 165
Texas 141
New York 109
Maryland 99
Ohio 98
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Clinical Trial Progress for Liquid E-z-paque

Clinical Trial Phase

Clinical Trial Phase for Liquid E-z-paque
Clinical Trial Phase Trials
Phase 4 259
Phase 3 163
Phase 2/Phase 3 46
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Clinical Trial Status

Clinical Trial Status for Liquid E-z-paque
Clinical Trial Phase Trials
Completed 841
Recruiting 202
Not yet recruiting 135
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Clinical Trial Sponsors for Liquid E-z-paque

Sponsor Name

Sponsor Name for Liquid E-z-paque
Sponsor Trials
National Cancer Institute (NCI) 88
M.D. Anderson Cancer Center 27
Bayer 27
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Sponsor Type

Sponsor Type for Liquid E-z-paque
Sponsor Trials
Other 1622
Industry 696
NIH 217
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Serving leading biopharmaceutical companies globally:

Harvard Business School
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Boehringer Ingelheim

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