View clinical trials related to Healthy Adult Subjects.
Filter by:This is a Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions.The objective is To characterize the bioequivalence、safety and tolerability of TTYP01 tablets and Radicava® injection or Radicava ORS®in healthy adult subjects under fasted conditions.In this study, 30 healthy adult subjects will receive TTYP01, or Radicava, orRadicava ORS in each period according to the randomization sequence.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of ID110521156 in healthy adult sbujects. This is the first clinical study of ID110521156.
This is a single-center, randomized, open-label, single-dose, parallel-designed PK similarity study.
This is an open-label, single-sequence, 2-period crossover study in healthy subjects. In this study, 20 subjects will be enrolled to allow at least 16 evaluable subjects. Subjects will receive a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) on Day 1 (Period 1) and on Day 29 (Period 2), and 600 mg efavirenz once a day from Days 15 through 42 (Period 2).
The goal of this clinical trial is toevaluate the safety and tolerability of a single dose of CRB4101 tablets in healthy adults . The main questions it aims to answer are: - [question 1]The pharmacokinetics (PK) and pharmacodynamic dynamics (PD) characteristics of CRB4101 tablets were evaluated in healthy adults after a single administration. - [question 2]Exploratory analysis of the relationship between serum concentrations of CRB4101 (and its major metabolites, if necessary) and QTc interphase. - [question 3]Exploratory analysis of the metabolic and excretory characteristics of CRB4101 after a single administration (if necessary) - [question 4]Exploratory analysis of pharmacokinetic characteristics of major metabolites of CRB4101 (if necessary) - [question 5]The influence of pharmacogenomics on pharmacokinetic characteristics (if necessary). After the participants who signed the informed consent have been screened by the inclusion criteria, those who meet the inclusion criteria and those who do not meet the exclusion criteria will receive the following 6 dose groups in order from low to high: 100mg, 200 mg, 400 mg, 800 mg, 1200 mg, 1600 mg
Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as a single 50 mg/0.5 mL SC dose.
To evaluate the effect of food on the pharmacokinetics of oral edaravone in healthy adult subjects. In this study, we determined 5 different dietary conditions including 4 different meal contents and fasting condition.
A single-center, open-label, randomized, two-period, crossover study design of pharmacokinetics and bioavailability in healthy adult male and female subjects under fasting conditions.
This is a phase 1 single-center study to assess the pharmacokinetics (PK), safety and tolerability of KT07 capsules in healthy adult subjects. This study consists of 2 parts: Part 1 and Part 2. The primary objectives of Part 1 include selection of suitable PK markers for bioanalysis, development and validation of GLP bioanalytical methods for follow-up PK studies, assessment of PK of potential markers following an oral administration of KT07, and provision of PK sampling strategy for Part 2. The primary objective of Part 2 is to evaluate the PK profile following a single dose and multiple doses in healthy adult subjects.
This study will evaluate the absorption,metabolism and excretion of CBP-307 in healthy chinese male subjects.