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The aim of the study is to identify neural signatures, behavioral and phenomenological expressions of self-related processes including: sense of agency, semantic distinction between self and other, selflessness (altruism), social agency, embodied self (interoception), perceptual functioning of dissolved self including hallucinations and crossmodal processing, and finally the mystical type dissolution of the self.
To assess how long extended release prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI). To evaluate the safety of several extended release capsule formulations (LYN-PLT) and a placebo capsule.
It is well known that dietary protein is a powerful transient stimulator of the muscle protein synthetic rate (MPS) whereby changes in MPS in response to feeding may be regulated by specific downstream target proteins of mammalian target of rapamycin signaling, such as S6K1, rpS6, and eIF2B. A meal deficient in protein, however, does not increase the rate of MPS because a rise in the bioavailability of amino acids does not occur. In addition, the source of dietary proteins has been shown to impact postprandial blood levels of amino acids. The concept that certain types of proteins are "fast acting" or "slow acting" has been shown to affect the postprandial profile of amino acids appearing in the systemic circulation. Native whey and micellar casein are both dairy proteins that contain a similar amount of essential (EAA), but blood EAA levels increase faster and to a higher level after the consumption of whey protein. Differences in gastric emptying, digestion and absorption kinetics between micellar casein and native whey are the underlying factors. Nonetheless, micellar casein protein has been shown to protract MPS in humans. Despite the significant amount of information gained with respect to both of these protein sources, the effects of combinatorial formulations on the postprandial profile of amino acids appearing in the blood is less well known. The purpose of the present study is to determine post-ingestion aminoacidemia, glycemia, and insulinemia from a specially formulated dairy protein blend.
To assess how long memantine hydrochloride (HCl) (50 mg) extended release capsules stay in the stomach as determined by imaging assessment (MRI or abdominal ultrasound). To evaluate the safety of a memantine HCl extended release capsule formulation
This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating the SmartSleep product, including SleepMapper app in the home setting. It is intended to provide data related to product use and cognitive testing incorporating a longer baseline period for comparison purposes. It will include adults (21-50 yr. old) who are working full time and report shortened sleep due to lifestyle. For the purposes of this study, shortened sleep is defined as sleeping at least 5 hrs. of sleep per night, and sleeping less than or equal to 7 hrs. at least 3 nights per week. Participants also increase their sleep duration by ≥ 1 hour on the weekends. In addition, participants report a sleep latency ≤ 30 minutes less than or equal to 3 nights per week. Participants are generally healthy individuals who have not been diagnosed with any sleep-related medical conditions. In addition, participants diagnosed with major organ system diseases or requiring oxygen therapy are excluded from participation. Up to 75 individuals will be consented in order to complete a total of 50 participants using a nonrandomized design. The study involves an initial screening visit followed by home use of the SmartSleep device with SleepMapper app. The home use will include an initial week of baseline use followed by 3 weeks of use with boost on. Study staff will contact participants after the first week of use as a reminder. Participants will be asked to complete a battery of cognitive tests upon wake up each morning. Participants will be asked to complete a question twice daily during the home use period. Additional phone calls may occur on an as needed basis if issues arise. The final visit will be an in facility visit in which all study equipment will be returned. The anticipated study duration will be up to 6 weeks (including the 4 weeks of use period).
The main objectives of the study are as follows: - To assess the mass balance recovery of [14C]-radioactivity in urine and faeces after a single oral dose of 50 mg BI 730357 BS (C-14) in healthy male subjects - To provide plasma, urine, and faecal samples for metabolite profiling and structural identification
This trial intends to investigate the basic pharmacokinetics of BI 425809 and [14C]- radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 25 mg BI 425809 (C-14) given to healthy male subjects
This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of PBI-4050 combined with midazolam in healthy adult subjects.
The objective of this study is to establish the bioequivalence of two levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.
This study will examine how Brain Power Score, an objective measure of brain function, is affected by the presence of smartphone push notifications.