Clinical trials: BALANCE
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).
- Trial name
- NCT07159841
- Testing
- Atumelnant
- Where
- 51 sites in United States, Argentina and 11 more
- Volunteers
- 153 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Parkinson Disease
Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156
The study is designed to determine the absorption, distribution, metabolism and elimination (ADME) of BIA 28-6156 in humans, further explore the PK of BIA 28-6156, evaluate the extent of distribution of total radioactivity into…
- Trial name
- NCT05220072
- Testing
- Carbon-14 BIA 28-6156
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bial R&D Investments, S.A.
Healthy Volunteer
Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125
This study is conducted to evaluate the absolute bioavailability, metabolism and elimination pathways of AQX-1125 in healthy male and female subjects.
- Trial name
- ADME (NCT03185195)
- Testing
- AQX-1125 Oral Tablet, [14C]-AQX-1125 IV, [14C]-AQX-1125 Oral Solution
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
Fasting
Bioequivalence Study of Risperidone Tablet 1 mg Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01722201
- Testing
- Risperidone Tablet 1 mg, Risperidone
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Diabetes Mellitus, Type 2
OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under…
- Trial name
- NCT01842620
- Testing
- Metformin
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes
A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)
A single dose, open label study to characterize the routes of elimination and determine the mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male participants with type 2 diabetes.
- Trial name
- NCT00912002
- Testing
- MK-0941
- Volunteers
- 6 people
- Sponsor
- Merck Sharp & Dohme LLC
Food-drug Interaction
A Food Effect Study of 60mg ER Torsemide
This study will evaluate the effects of a high-fat meal (food effect) on the bioavailability and pharmacokinetics of 60mg ER Torsemide tablet after single dose oral administration in healthy volunteers.
- Trial name
- NCT03215875
- Testing
- Fed- 60mg ER Torsemide, Fasting- 60mg ER Torsemide
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sarfez Pharmaceuticals, Inc.
Healthy
A Mass Balance Study of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371-microtrace
The primary objectives of the study are: To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects
- Trial name
- NCT03492996
- Testing
- LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose
- Where
- South Korea
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- LigaChem Biosciences, Inc.
Healthy
Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with Depakote® Sprinkle125 mg capsules in…
- Trial name
- NCT01132183
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Respiratory Disorders, Asthma and Rhinitis
Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions
This study is conducted to determine whether the test product (GW483100 10 mg containing montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference montelukast sodium 10 mg tablets (innovator…
- Trial name
- NCT02658422
- Testing
- Test Montelukast, Reference Montelukast
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma
Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594
AZD7594 is in clinical development for the treatment of asthma. This is a single centre, open-label, single period study in 6 healthy subjects, to determine the mass balance recovery and generate samples to enable metabolite…
- Trial name
- NCT04002427
- Testing
- Intravenous Infusion, Inhaled dose
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Advanced Solid Tumors, Lymphoma
Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB
This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable participants with advanced solid tumors or lymphoma.
- Trial name
- NCT01953783
- Testing
- IXAZOMIB
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Muscular Dystrophy, Duchenne
Modified Diet Trial: A Study of SMT C1100 in Paediatric Patients With DMD Who Follow a Balanced Diet
Placebo-controlled, multi-centre, randomized, double-blind dose escalation study. The aim is to evaluate the pharmacokinetics (PK) and safety of SMT C1100 in paediatric patients with Duchenne Muscular Dystrophy (DMD) who follow a…
- Trial name
- NCT02383511
- Testing
- SMT C1100
- Where
- 4 sites in United Kingdom
- Volunteers
- 12 people
- Sponsor
- Summit Therapeutics
Gastrointestinal Symptoms
Safety Evaluation of a Diet and Nutritional Supplementation Program- Purify 2.0
The study evaluated the safety, tolerability and acceptability of a lifestyle modification program with nutritional supplementation designed to restore balance to healthy bowel function in generally healthy subjects
- Trial name
- NCT03685552
- Testing
- Prog: Purify-2
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Nature's Sunshine Products, Inc.
Healthy
Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to 1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl tablets of Dr.
- Trial name
- NCT01136525
- Testing
- Valacyclovir Hydrochloride
- Where
- India
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Contraception, Female Contraception
A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive)
The objective of this study is to estimate exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in healthy female volunteers across multiple commercial lots of EVRA® (a transdermal contraceptive patch…
- Trial name
- NCT00258063
- Testing
- EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.60 mg of ethinyl estradiol (versus CILEST® tablets).
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition
To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil®PM, of Wyeth consumer health care, USA, in normal, healthy…
- Trial name
- NCT01053338
- Testing
- Ibuprofen and Diphenhydramine Citrate
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Fasting State
Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01578252
- Testing
- Ondansetron Tablets USP 8 mg, Ondansetron Hydrochloride
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Schizophrenia
Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpiprazole)
Single dose oral bioequivalence study of Brexpiprazole 4 mg Film Coated Tablets and RXULTI® (Brexpiprazole) 4 mg film-coated tablets in healthy adult human subjects under fasting conditions.
- Trial name
- NCT07266792
- Testing
- Brexpiprazole Film Coated Tablets, RXULTI film coated tablet
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Solid Tumors
An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors
The main aim of this study is to assess how the human body of adults with advanced or metastatic solid tumors absorbs, distributes, metabolizes and excretes subasumstat following a single 1 hour infusion of subasumstat.
- Trial name
- NCT05976334
- Testing
- [14C] Subasumstat, Subasumstat
- Where
- 2 sites in Hungary
- Volunteers
- 3 people
- Sponsor
- Takeda