View clinical trials related to Healthy Volunteers.
Filter by:The purpose of this study is to assess the effect of food on the bioavailability of venglustat and to assess the relative bioavailability of venglustat tablet swallowed whole with water versus a tablet chewed and then swallowed without water. Also, to evaluate the safety and tolerability of a single dose tablet of venglustat under fed (swallowed whole) and fasted (swallowed whole or chewed) conditions in healthy adult participants. The maximum duration for participants from screening is up to 63 days.
The purpose of this study is to assess the bioequivalent effect of venglustat in tablet and hard capsule form when give with water under fasting conditions. Also, to evaluate the safety and tolerability of a single dose tablet and hard capsule of venglustat (swallowed whole) under fasting conditions in healthy adult participants. The maximum duration for participants from screening is up to 47 days.
This is a single-center, open-label, single-dose, randomized, 3-period cross-over, Phase 1 study in healthy adult participants to assess the BA of AGMB-129 tablet formulation relative to that of the reference capsule formulation and to assess the effect of food on the BA of a single oral dose of the AGMB-129 tablet formulation. A total of 24 participants will be enrolled. Participants will be randomized to 1 of 6 intervention sequences (Williams design) according to a 6-sequence, 3-period design. In 3 sequential intervention periods, each participant will receive 3 study interventions, 1 in each intervention period. The total duration of involvement for each participant, screening through follow-up, will be approximately 6 weeks.
This usability validation testing protocol outlines the methods being used to demonstrate and gather evidence that the current design and user experience of the Spire Remote Patient Monitor are safe and effective for use by the people who are representative of the intended users under expected use conditions. This summative testing is the culmination of several preliminary analyses including a formative usability evaluation via Cognitive Expert Review Panel and is intended to assess the effectiveness of control measures put in place to reduce/eliminate use-related hazards or potential use errors.
This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age. The total study duration per participant is expected to be up to 36 days, including: - Screening: up to 4 weeks - Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods. - Washout: One day washout is planned after each treatment period hence providing 2 days between doses. - Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study.
This clinical study is a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical study to assess the PK characteristics and safety and tolerability of single and multiple dose daridorexant in 32 healthy adult Chinese subjects.
The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects.
The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-552 in healthy, male volunteers following administration of a single oral dose.
The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body. Other aims are to learn how safe the treatment with TAK-721 is and how suitable the TAK-721 is for healthy adults who either fasted or had eaten. All participants will receive TAK-721 but half will be assigned by chance to the participant group who are fasting first then getting the high-fat/high-calorie meal later or the group who gets meal first and fasts later. The group assignment will be switched once during the course of the study so that all participants will receive TAK-721 in both a fasted or fed condition.
The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers. Participants will receive single-dose of either test or reference octreotide microsphere formulations. Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.