CLINICAL TRIALS PROFILE FOR COLD CAPSULE V
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505(b)(2) Clinical Trials for Cold Capsule V
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT00009542 ↗ | Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan | Completed | National Institutes of Health Clinical Center (CC) | Phase 4 | 2001-01-01 | This study will examine how kava-a widely used herbal remedy-may affect the body's elimination of other medicines. Many people take kava to reduce anxiety or cause sedation. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between kava and other medications. This study will look at how kava affects the elimination of caffeine-a compound commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough suppressant. Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age will have a urine pregnancy test. Study participants will not drink alcoholic beverages or take any medications (except those given in the study) for 2 weeks prior to the study and throughout its duration. In addition, they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at least 72 hours before and throughout each study day that urine is collected. On day 1 of the study, study subjects will take one dose each of caffeine and dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then collect all their urine after the dosing for the rest of the day and including the next mornings first urine. They will bring the urine samples to the Clinical Center when the collection is complete. This procedure will be repeated 1 week later (study day 8). After the second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the dextromethorphan and caffeine dosing and urine collection described above, while continuing to take kava. Subjects will have an electroencephalograph (EEG) done before starting kava and again at the end of kava (study day 30). For this procedure, several electrodes (metal cups attached to wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space between the electrode and the scalp to ensure good contact. The electrodes will remain in place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG recording. Participation in the study will end with another physical examination and blood tests following the second EEG and urine collection. |
| New Formulation | NCT00055263 ↗ | A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies | Completed | Novacea | Phase 1 | 2002-03-01 | The purposes of this study are to: - Test the safety of DN-101 in patients with advanced malignancies - Understand how fast the body absorbs, processes, and eliminates DN-101 - Determine the highest dose of DN-101 that is well tolerated by cancer patients - Learn how fast the body absorbs, processes, and eliminates DN-101 compared to the approved product |
| New Formulation | NCT00498745 ↗ | Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects | Completed | Puma Biotechnology, Inc. | Phase 1 | 2007-07-01 | To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects. |
| New Formulation | NCT00499538 ↗ | Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult Subjects | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | Phase 1 | 2007-07-01 | To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a reference capsule and an oral solution in healthy subjects. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Cold Capsule V
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000152 ↗ | Randomized Trial of Beta-Carotene and Macular Degeneration | Unknown status | National Eye Institute (NEI) | Phase 3 | 1982-04-01 | To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake. |
| NCT00000461 ↗ | Harvard Atherosclerosis Reversibility Project (HARP) | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 | 1986-12-01 | To determine by sequential coronary arteriography whether a lipid-lowering diet with and without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic patients. Also, to test whether fish oil supplements could improve human coronary atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. At least three clinical trials were conducted. |
| NCT00000500 ↗ | Physicians' Health Study | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 1981-09-01 | To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene. |
| NCT00000500 ↗ | Physicians' Health Study | Completed | Brigham and Women's Hospital | Phase 3 | 1981-09-01 | To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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