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Last Updated: January 22, 2020

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CLINICAL TRIALS PROFILE FOR LIQUID PRED

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505(b)(2) Clinical Trials for Liquid Pred

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 N/A 2009-03-01 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Liquid Pred

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Liquid Pred

Condition Name

Condition Name for Liquid Pred
Intervention Trials
Healthy 64
Cystic Fibrosis 19
HIV Infections 19
Breast Cancer 18
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Condition MeSH

Condition MeSH for Liquid Pred
Intervention Trials
Diabetes Mellitus 41
Infection 33
Diabetes Mellitus, Type 2 32
HIV Infections 26
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Clinical Trial Locations for Liquid Pred

Trials by Country

Trials by Country for Liquid Pred
Location Trials
Canada 139
United Kingdom 87
Germany 69
France 61
Spain 54
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Trials by US State

Trials by US State for Liquid Pred
Location Trials
California 125
Texas 107
New York 83
Maryland 82
Ohio 74
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Clinical Trial Progress for Liquid Pred

Clinical Trial Phase

Clinical Trial Phase for Liquid Pred
Clinical Trial Phase Trials
Phase 4 199
Phase 3 132
Phase 2/Phase 3 30
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Clinical Trial Status

Clinical Trial Status for Liquid Pred
Clinical Trial Phase Trials
Completed 573
Recruiting 203
Not yet recruiting 144
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Clinical Trial Sponsors for Liquid Pred

Sponsor Name

Sponsor Name for Liquid Pred
Sponsor Trials
National Cancer Institute (NCI) 71
M.D. Anderson Cancer Center 23
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 22
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Sponsor Type

Sponsor Type for Liquid Pred
Sponsor Trials
Other 1086
Industry 505
NIH 180
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