Clinical trials: BALANCE
Healthy
Bioequivalence Study of Cyclobenzaprine Hydrochloride 10 mg Tablets, USP Under Fasting Conditions
To compare the single-dose oral bioavailability of Cyclobenzaprine hydrochloride 10 mg tablet of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg tablet (containing Cyclobenzaprine…
- Trial name
- NCT00778037
- Testing
- Cyclobenzaprine hydrochloride 10 mg tablet
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed 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
- NCT01132196
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Allergic Rhino-Conjunctivitis, Urticaria
To Compare and Evaluate the Oral Bioavailability of Bilastine 20 mg Orally Dispersible Tablet With That of Bilaxten (Bilastine) 20 mg Orally Dispersible Tablet in Healthy, Adult, Human Subjects Under Fasting Conditions
An open label, balanced, randomized single-dose, two-treatment, two sequence, four-period, Full Replicate, crossover oral bioequivalence study in healthy, adult, human subjects under fasting condition.
- Trial name
- NCT07042828
- Testing
- Bilastine oral dispersible tablets, Bilaxten oral dispersible tablets
- Where
- India
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Colon Cancer, Breast Cancer
A Bioequivalence Study of Capecitabine Tablets 500 mg in Adult Cancer Patients Under Fed Condition
Purpose: To demonstrate the bioequivalence between Capecitabine Tablets 500 mg of Qilu Pharmaceutical Co., Ltd, China in comparison with XELODA® (Capecitabine) Tablets 500 mg, Distributed by Genentech USA, Inc.
- Trial name
- Capecitabine (NCT03435666)
- Testing
- Capecitabine, XELODA
- Volunteers
- 45 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy Adult Subjects
Mass Balance Study of [14C]DA-302168S in Healthy Chinese Adult Male Participants
In this study, a single dose of [14C] radiolabelled DA-302168S will be administered orally. The main purpose of this study is to find out how much of DA-302168S and its metabolites pass from blood into urine and feces, and…
- Trial name
- NCT07857265
- Testing
- [14C] DA-302168S
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis
Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System
The primary objectives of this evaluation are: 1) To attempt to refine the current clinical understanding of "balance" 2) To determine if patients with quantifiably balanced knee joints exhibit improved clinical outcomes versus…
- Trial name
- NCT01469299
- Where
- 8 sites in United States
- Volunteers
- 285 people
- Sponsor
- Orthosensor, Inc.
Skin Microboime, Acne
Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
The purpose of this study is to assess the safety of the skin balancing gel cream and examine the effects it has on the skin microbiome of individuals with non-cystic acne prone skin.
- Trial name
- NCT05941065
- Testing
- Balancing gel cream
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Integrative Skin Science and Research
Healthy Volunteer
A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration
The purpose of this study is to evaluate the mass balance and safety of [14C] ABBV-903 in healthy male volunteers following a single oral dose administration.
- Trial name
- NCT05995366
- Testing
- ABBV-903
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- AbbVie
Healthy
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting Conditions
This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT03696329
- Testing
- Tetrabenazine Tablets 25 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
14C-ARN-509 Microtracer Label AME and Absolute BA Study
This is study in healthy human volunteers to determine the absorption, metabolism, and excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).
- Trial name
- NCT01822041
- Testing
- ARN-509
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aragon Pharmaceuticals, Inc.
Cardiovascular Diseases
An ADME Study of [14C]AZD0780 in Healthy Male Subjects
The Sponsor is developing a new test medicine, AZD0780, with the aim to lower low-density lipoprotein cholesterol (LDL-C, fatty deposits) levels and cardiovascular (heart disease) risk, when given on top of standard care.
- Trial name
- NCT05817461
- Testing
- AZD0780 tablet, [14C]AZD0780 Solution for Infusion, [14C]AZD0780 Oral Solution
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Nervousness, Restlessness
Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness
Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12. Each patient is treated with NPB. No placebo group is established.
- Conditions
- Nervousness, Restlessness, Depression (Agitated), Affective Disorders
- Trial name
- NCT01125579
- Where
- Germany
- Volunteers
- 115 people
- Sponsor
- Pascoe Pharmazeutische Praeparate GmbH
Healthy
Bioequivalence Study of Paricalcitol Capsules, 4 mcg Under Fasting Conditions
An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study in healthy subjects under fasting conditions.
- Trial name
- NCT02322632
- Testing
- Paricalcitol Capsules, 4 mcg
- Where
- India
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Multiple Sclerosis
An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)
The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at…
- Trial name
- NCT01535664
- Testing
- Withdrawal of dalfampridine-ER 10mg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Acorda Therapeutics
Diabetes, Healthy
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.
- Trial name
- NCT01527565
- Testing
- biphasic insulin aspart 70
- Where
- South Africa
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy Volunteers
Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101
This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult male subjects.
- Trial name
- NCT04952467
- Testing
- 14C-XEN1101
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Xenon Pharmaceuticals Inc.
Healthy Volunteers
A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults
This will be an open-label, non-randomized, single oral dose study in healthy male subjects. All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL), containing NMT 1.3 MBq (37 μCi) 14C.
- Trial name
- NCT02994381
- Testing
- RPC1063
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Celgene
Healthy Volunteer
Metabolism and Excretion of [14C]CC-90001 in Healthy Male Subjects
This is a clinical pharmacology study to characterize the biotransformation and excretion of [14C]CC-90001 and to evaluate the safety and tolerability of [14C]CC-90001 following a single oral dose of [14C]CC-90001 in healthy male…
- Trial name
- NCT04655898
- Testing
- [14C]CC-90001
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Celgene
Pharmacokinetics
A Study Assessing the Mass Balance of a Single Oral Dose of [14C] DS-8500a in Healthy Subjects
This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age, inclusive.
- Trial name
- NCT02790684
- Testing
- DS-8500a
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Type 2 Diabetes Mellitus, Weight Loss
Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects
This study was a single-center, single-dose, open-label study in healthy male subjects to investigate the absorption, metabolism and excretion of HRS9531 after a single subcutaneous injection of [14C]HRS9531.
- Trial name
- NCT06855147
- Testing
- [14C]HRS9531
- Where
- China
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.