CLINICAL TRIALS PROFILE FOR LIQUID E-Z-PAQUE
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505(b)(2) Clinical Trials for LIQUID E-Z-PAQUE
| 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. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >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." |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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