Clinical trials: Drug Therapy
Ascending Single Dose Study
Safety, Tolerability and Pharmacokinetics of TAK-438 in Healthy Male Participants
The primary purpose of this study was to evaluate the single dose safety and pharmacokinetics of TAK-438 in healthy Japanese men.
- Trial name
- NCT02123927
- Testing
- TAK-438
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Takeda
Small Cell Lung Carcinoma Extensive Disease
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with…
- Trial name
- CANTABRICO (NCT04712903)
- Testing
- Durvalumab, Cisplatin, Etoposide
- Where
- 34 sites in Spain
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fasting Conditions
Objective: Primary objective of the present study was to compare the single dose bioequivalence of Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the fed were separated by a washout period of 7 days.
- Trial name
- NCT01634386
- Testing
- Torrent's Quetiapine Fumarate Tablets
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
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
Bioequivalence Study of Mirabegron From Bladogra 25 mg Extended Release Tablets (Multi-Apex for Pharmaceutical Industries, Egypt) Versus Myrbetriq 25 mg Extended Release Tablets (Marketed by Astellas Pharma US, Inc, Product of Japan)
An open label randomized, single dose, three way three sequence two treatment partial replicate crossover study to determine the bioequivalence of Mirabegron from Bladogra 50 mg Extended Release film coated tablets (Man by…
- Trial name
- NCT04476966
- Testing
- Bladogra, Myrbetriq (first dosing), Myrbetriq (second dosing)
- Where
- Egypt
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy Volunteers
A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation
The purpose of this study is to assess the PK of TAK-536 and effect of food on the PK following single oral administration of TAK-536 pediatric formulation in Japanese healthy adult male participants.
- Trial name
- NCT03434977
- Testing
- TAK-536
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Amyotrophic Lateral Sclerosis (Healthy Volunteers)
A Study in Healthy Adult Male & Female Participants to Assess the Amount of the Study Medicine (SAR443820) Absorbed by the Body, When Given Orally in Fasted Condition as a Tablet Versus as a Capsule (Part 1) and When Given Orally as a Tablet in Fasted Condition Versus as a Tablet After Food (Part 2)
Part 1: This is an open label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment A and Treatment B for Part 1), study part to determine the relative…
- Trial name
- NCT05797701
- Testing
- SAR443820
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
Bioavailability of Aliskiren and Valsartan as a Single Tablet vs. the Same Doses of the Two Drugs Given Separately to Healthy Subjects.
This study will assess the bioavailability of aliskiren and valsartan as a single tablet compared to the same doses of the two drugs given as two separate tablets in healthy subjects.
- Trial name
- NCT00416728
- Testing
- Aliskiren, Valsartan
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04400682)
- Testing
- FAVIRA 200 MG Film Tablet, AVIGAN 200 MG Film Tablets
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novelfarma Ilaç San. ve Tic. Ltd. Sti.
Injection Site Reaction
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints.
- Trial name
- NCT06093815
- Testing
- Injection
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.
Viral Respiratory Tract Infection
Safety and Tolerability of Single and Multiple Doses of Neumifil
This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of…
- Trial name
- NCT05093530
- Testing
- Neumifil
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pneumagen Ltd.
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal…
- Trial name
- NCT03482453
- Testing
- TAK-788
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy Volunteers
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03948581
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Takeda
Hypertension
Digital Health for Medication Adherence Among African Americans With Hypertension
The proposed Phase 1 project aims to develop and test Memento.HTN, an individually-tailored, culturally sensitive digital health intervention comprised of a provider platform and linked patient SMS (short message service) text…
- Trial name
- NCT05009004
- Testing
- text messages to support medication adherence
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Environment and Health Group, Inc.
Hepatic Impairment, Healthy Volunteers
A Study of TAK-279 in Adults With or Without Liver Damage
The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with liver problems compared to participants without liver problems.
- Trial name
- NCT05976321
- Testing
- TAK-279
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fasting Conditions
The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8 mg orally disintegrating tablets of OHM Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc, USA) with Zofran ODT® 8 mg…
- Trial name
- NCT01523093
- Testing
- Ondansetron
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Gastroesophageal Reflux Disease, Erosive Esophagitis
Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets
The purpose of this study is to measure the in-vivo disintegration time of a single dexlansoprazole delayed-release orally disintegrating (OD) tablet.
- Conditions
- Gastroesophageal Reflux Disease, Erosive Esophagitis, Heartburn
- Trial name
- NCT02096458
- Testing
- Dexlansoprazole
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Takeda
Fed
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fed Conditions
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
- NCT01827878
- Testing
- Lisinopril and Hydrochlorothiazide Tablets (20+25) mg, Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions
The objective of this study was to compare the relative bioavailability of Lansoprazole DR Capsules 30 mg with Prevacid® Capsules 30 mg under fasting conditions in healthy adult human subjects.
- Trial name
- NCT01270308
- Testing
- Lansoprazole
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Obesity
First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of ACCG-2671
This first-in-human study will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of ACCG-2671.
- Trial name
- NCT07815678
- Testing
- ACCG-2671
- Where
- 6 sites in United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics