Clinical trials: Balanced
Healthy
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fed Conditions
The purpose of this study is To compare the single oral dose bioavailability of test product, Trandolapril 4 mg Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult, human subjects, under fed…
- Trial name
- NCT01164800
- Testing
- Trandolapril, Mavik
- Where
- India
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Subjects
A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects
The main objectives of this first-into-man study were to investigate the safety, tolerability and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults.
- Trial name
- NCT02919319
- Testing
- ACT-541468 (Formulation A), ACT-541468 (Formulation B), 14C-labeled ACT-541468
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
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
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
HIV Infections
Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
- Trial name
- NCT07636928
- Testing
- VH4524184, [14C]VH4524184 microdose, [14C]VH4524184
- Where
- Netherlands
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
A Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance and Metabolism of PF-07265803
The purpose of this study is to assess the pharmacokinetics, excretion, mass balance and metabolism of PF-07265803 (formerly known as ARRY-371797) in approximately 6 healthy adult male participants.
- Trial name
- NCT05286281
- Testing
- PF-07265803
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Psoriasis and Psoriatic Arthritis
Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects
An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting condition
- Trial name
- NCT06084663
- Testing
- Apremilast 30 mg Tablets, Otezla 30 mg film-coated tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Fasting
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Fasting Conditions
To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under…
- Trial name
- NCT01283841
- Testing
- Mycophenolate Mofetil
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Heart Failure
A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5462 and the Absolute Bioavailability of AZD5462
A study to investigate how the body breaks down and gets rid of the test medicine, AZD5462. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14)…
- Trial name
- NCT06989983
- Testing
- AZD5462 film-coated tablet, [14C]AZD5462 Solution for Infusion, [14C]AZD5462 Oral Solution
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type 2 Diabetes
Bioequivalence Study of Test Product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg Film Coated Tablets and Reference Product (R) of Segluromet 7.5 mg/ 1000 mg Film Coated Tablets in Healthy, Adult, Human Subjects Under Fed Condition.
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, Two way crossover, Oral Bioequivalence Study of test product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg film coated tablets of Humanis…
- Trial name
- NCT07266779
- Testing
- Ertugliflozin/Metformin film coated tablets, Segluromet film coated tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Lymphoma
A Study to Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Volunteers
Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Male Volunteers.
- Trial name
- NCT06010680
- Testing
- [14C]SHR2554
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition
This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA Inc., Group of Roche, South San Francisco in…
- Trial name
- NCT02296723
- Testing
- Valganciclovir Hydrochloride
- Where
- India
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Acute Leukemia
Study of Radiolabeled Revumenib in Adults With Acute Leukemia
This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 ([14C])-revumenib in participants with acute leukemia.
- Trial name
- NCT05406817
- Testing
- Revumenib
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Syndax Pharmaceuticals
Anxiety Disorders
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
This study will be conducted to evaluate and compare the single oral dose bioavailability of Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline México, S.A. de C.V.
- Trial name
- NCT04311463
- Testing
- Paroxetine hydrochloride, PAXIL (Paroxetine hydrochloride )
- Where
- Mexico
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Subjects, Human Volunteers
Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects
A randomized, open label, single dose, balanced, two treatment, two sequence, four period, fully replicate, cross over bioequivalence study under fasting condition.
- Conditions
- Healthy Subjects, Human Volunteers, Healthy Participants, Bioequivalence
- Trial name
- NCT05519514
- Testing
- Cortiment, Budesonide
- Where
- India
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Abbott
Healthy
Mass Balance Study of MT-3995
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects.
- Trial name
- NCT02900235
- Testing
- MT-3995
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Infections, Bacterial
A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 After an Intravenous and an Oral Dose
This is a phase 1, non-randomized, open label, single-dose, two-period, cross-over study. This study will utilize 14C radiolabeled GSK1322322 to investigate the recovery, excretion, and pharmacokinetics of GSK1322322 in 6 healthy…
- Trial name
- NCT01663389
- Testing
- GSK1322322 1000 mg containing radioactive 14C-GSK1322322, GSK1322322 1200 mg containing radioactive 14C-GSK1322322
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
MB
Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants
This trial adopts a single-center, open-label, non-randomized, single-dose study design. It is planned to enroll 6 healthy Chinese male participants, and the final standard is to collect complete samples and data to be tested…
- Trial name
- NCT07809217
- Testing
- 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Healthy Adult Male
Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of [14C]HRS-9190 in healthy Participants
- Trial name
- NCT07494175
- Testing
- [14C] HRS-9190
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Smoking Behaviors
Nicotine Pouch Pharmacokinetics Abuse Liability
Nicotine pharmacokinetics and subjective effects of Investigational Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.
- Trial name
- NCT07476144
- Testing
- Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.
- Where
- 2 sites in United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- JT International SA