Clinical trials: BALANCE
Healthy Participants
Mass Balance Clinical Trial With TEV-56286
Mass balance clinical trial with TEV-56286
- Trial name
- NCT06627231
- Testing
- TEV-56286, [14C]-TEV-56286
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Healthy
Bio-equivalency Study of Moxifloxacin Tablets, 400 mg Under Fasting Conditions
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in human subjects under fasting conditions.
- Trial name
- NCT02322619
- Testing
- Moxifloxacin Tablets 400 mg
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Anesthesia, Sedation
A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults
This study is designed to evaluate the mass balance in healthy Chinese male subjects after receiving a single dose of intravenous [14C]HSK3486, so as to assess the overall pharmacokinetics and safety of HSK3486 in humans and…
- Trial name
- NCT03751969
- Testing
- HSK3486
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Healthy Volunteers
Pharmacokinetic and Mass Balance Study of Oral-Administrated [14C]-DZD9008 in Healthy Male Subjects
This is a phase 1, open-label, ADME study with single oral administration of [14C]-DZD9008 in healthy subjects.
- Trial name
- NCT05159895
- Testing
- [14C]-DZD9008
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Dizal Pharmaceuticals
Vestibular Diseases, Labyrinth Diseases
Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance physical therapy for rehabilitation of patients who…
- Conditions
- Vestibular Diseases, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases
- Trial name
- SEMD (NCT01483937)
- Testing
- Usual care physical therapy plus SEMD, Usual care physical therapy only
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Karen L Atkins
Healthy
Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects
The primary objectives of this study are: To determine the mass balance recovery (expired air, urine and faeces) and route and rate of elimination of 14C-Debio 1450.
- Trial name
- NCT02595203
- Testing
- [14C-pos 1]-Debio 1450 BES Solution, [14C-pos 25]-Debio 1450 BES Solution
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
Healthy
Bioequivalency Study of Divalproex Sodium DR Tablets, 500 mg of Dr.Reddy's Under Fasting Conditions
The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets 500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy subjects.
- Trial name
- NCT01132170
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Diabetic Foot
BE STUDY OF METFORMIN GSK 1000mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition.
- Trial name
- BA/BE 199/11 (NCT01710553)
- Testing
- Glucophage 1000mg, Metformin GSK 1000mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Male Subjects
A Human AME Study for Omaveloxolone
This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of [14C] omaveloxolone and derived metabolites following administration as a single 150 mg (containing…
- Trial name
- NCT03931590
- Testing
- [14C]-Omaveloxolone
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Biogen
Chronic Stroke Survivors
PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study
Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors. Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing…
- Trial name
- NCT06336720
- Testing
- Portable Neuromodulation Stimulator (PoNS)
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Helius Medical Inc
Healthy Male Volunteers
Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Healthy Adult Male Subjects
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single oral dose of [14C]-20 mg/100 μCi Anaprazole Sodium enteric-coated capsule in healthy adult male subjects.
- Trial name
- NCT04476394
- Testing
- [14C]-Anaprazole Sodium enteric-coated capsule
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
Healthy
Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fasting Study
This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of OHM Laboratories…
- Trial name
- NCT01654705
- Testing
- Pantoprazole
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
NASH With Fibrosis
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431).
- Trial name
- NCT05737433
- Testing
- [14C]-rencofilstat 225mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Healthy
A Study to Test How BI 1819479 is Taken up and Processed by the Body
This trial is intended to investigate the mass balance, metabolism, and basic pharmacokinetics of BI 1819479 (C-14) (Part A) and to investigate the absolute bioavailability of BI 1819479 (Part B) in healthy male volunteers.
- Trial name
- NCT07065617
- Testing
- [14C]BI 1819479, BI 1819479, BI 1819479 (C-14)
- Where
- United Kingdom
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Dyslipidemia
ADME Study in Healthy Male Subjects With TA-8995
A study to measure the absorption, metabolism and excretion of a single dose of radiolabelled TA-8995 (10mg) in healthy male subjects.
- Trial name
- NCT02408055
- Testing
- TA-8995
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Xention Ltd
Healthy Volunteers
Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects
This is a single dose study of radiolabeled [14C]-LY3009104 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY3009104.
- Trial name
- NCT01299285
- Testing
- LY3009104
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Attention Deficit/Hyperactivity Disorder (ADHD)
To Compare and Evaluate the Oral Bioavailability of Lisdexamfetamine 70 mg Capsule With That of Elvanse® 70 mg Capsules, Hard Lisdexamfetamine Dimesylate in Healthy, Adult, Human Subjects Under Fasting Conditions.
An open label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study in healthy adult human subjects under fasting conditions.
- Trial name
- NCT07098585
- Testing
- Lisdexamfetamine capsule, Elvanse® (Lisdexamfetamine dimesylate capsules, hard)
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Arterial Hypertension (PAH)
Bioequivalence Study to Compare Selexipag 400 Microgram Film Coated Tablets Versus Uptravi® (Selexipag) 400 Microgram Film Coated Tablets
An open label, randomized, Three treatment, Three sequence, Three period, Three way crossover, single dose oral bioequivalence study to compare Selexipag 400 microgram film coated tablets versus Uptravi® (selexipag) 400 microgram…
- Trial name
- NCT07694128
- Testing
- Selexipag Film Coated Tablets (T1), Selexipag Film Coated Tablets (T2), Uptravi® (selexipag) film coated tablets
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy Volunteer
Human Mass Balance and Biotransformation Study of [14C]Afuresertib
This study adopts a single-center, single-dose, non-randomized, open-label design with a proposed enrollment of 6-10 healthy male subjects.
- Trial name
- NCT05489744
- Testing
- [14C]Afuresertib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Laekna Limited
Osteoarthritis, Knee, Rheumatoid Arthritis
A Comparison of Two Surgical Techniques Using the Unity Knee™ Total Knee System
A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis, Post-Traumatic Osteoarthritis of Knee, Varus Deformity, Not Elsewhere Classified, Knee
- Trial name
- NCT03511144
- Testing
- Unity Knee™ TKR using measured resection, Unity Knee™ TKR using ligament balancing
- Sponsor
- Corin