Clinical trials: Single Layer
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.
Irritable Bowel Syndrome, Abdominal Pain
Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
This is a pilot study to compare the relative bioavailability between two peppermint oil formulations, namely a ileocolonic release peppermint oil and an small intestinal release peppermint oil (Tempocol®).
- Conditions
- Irritable Bowel Syndrome, Abdominal Pain, Colonic Diseases, Visceral Pain
- Trial name
- NCT02291445
- Testing
- Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule), Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule)
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Healthy Volunteer
Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets
The objective of this study is to assess bioequivalence of lumacaftor from Lumacaftor 200 mg Film-Coated Tablet Formulation (Qanatpharma) versus the reference commercial product, Lumacaftor 200 mg /Ivacaftor 125 mg Combination…
- Trial name
- NCT05968612
- Testing
- Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet, Lumacaftor 200 mg Film-Coated Tablet Formulation
- Where
- Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Qanatpharma Canada LTD
Healthy Volunteer
Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers
The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects.
- Trial name
- NCT06388239
- Testing
- Apixaban 5MG
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy
Bioequivalence Study of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg FCT & Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)
An open label randomized, single dose, three-way, partial replicate bioequivalence study to determine the bioequivalence of Solifenacin Succinate \& Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma…
- Trial name
- NCT05767632
- Testing
- Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference first dose), Mirfenacin MR (Solifenacin Succinate 5 mg & Mirabegron 50 mg) (Test), Vesicare (Solifenacin Succinate 5 mg) & Betmiga (Mirabegron 50 mg) (Reference second dose)
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Uterus; Scar
UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation
We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique)
- Trial name
- NCT05517018
- Where
- Turkey (Türkiye)
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Gaziosmanpasa Research and Education Hospital
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine])…
- Trial name
- NCT05014490
- Testing
- Exib 120 mg etoricoxib film-coated tablets, Arcoxia® 120 mg etoricoxib film-coated tablets
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Bioequivalence, Type 2 Diabetes
Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Tablets in Healthy Male and Female Volunteers
The objective of this study was to determine the bioequivalence of two different formulations of sitagliptin/ metformin after a single oral dose administration under fed conditions.
- Trial name
- NCT05549583
- Testing
- Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Healthy Volunteers
Study to Compare the Pharmacodynamics and Pharmacokinetics of Acetylsalicylic Acid Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Healthy Adults.
The goal of this clinical trial is to compare the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of acetylsalicylic acid powder for oral inhalation (i-ASA) with non-enteric-coated chewable aspirin (C-ASA)…
- Trial name
- NCT05625334
- Testing
- ASA, non-enteric-coated chewable aspirin
- Where
- 2 sites in United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Vectura, Inc.
Healthy
Bioequivalence Study of Baricitinib From Barcimiant 4 mg Film Coated Tablets (Horus Pharma, Egypt) and Olumiant 4 mg Film Coated Tablets (Eli Lilly Nederland B.V., The Netherlands)
Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Baricitinib from Barcimiant 4 mg Film Coated Tablets (Horus Pharma…
- Trial name
- NCT05006768
- Testing
- Barcimiant, Olumiant (first dose), Olumiant (second dose)
- Where
- Egypt
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy Volunteer
Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product Under Fasting Conditions
This Study Aims to Assess the Relative Bioavailability, Including the Rate and Extent of Absorption, of 20 mg Leflunomide Tablets Compared to ARAVA® 20 mg Tablets.
- Trial name
- NCT06228443
- Testing
- Leflunomide 20 mg Film-coated Tablet, ARAVA® 20 mg Film-coated Tablet
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- International Bio service
Helicobacter Pylori Infection
The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets
A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in…
- Trial name
- NCT06337604
- Testing
- TNP-2092 capsules, Rabeprazole sodium enteric-coated tablets
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics Inc.
Healthy Volunteers, Pharmacokinetics
Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults
This is a Phase 1, open-label, single-dose crossover study designed to evaluate the effect of food on the pharmacokinetics of DW-1021, a fixed-dose combination tablet containing pelubiprofen 45 mg and tramadol 45.9 mg.
- Conditions
- Healthy Volunteers, Pharmacokinetics, Food Effect in Healthy Volunteers
- Trial name
- DW-1021F (NCT07060209)
- Testing
- DW-1021
- Where
- 2 sites in Vietnam
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Haiphong University of Medicine and Pharmacy
Depressive Disorder
Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects
The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile
- Trial name
- NCT00406003
- Testing
- Paroxetine controlled release tablet
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Atherosclerosis
A Study to Assess the Effect of SB 659032 on Platelet Function
This will be an open-label, single dose, single period study. Approximately 14 subjects will receive one dose of 250 mg of non-enteric coated SB-659032 following a low-fat breakfast.
- Trial name
- NCT01750827
- Testing
- SB659032
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Participants, Participants With Moderate Renal Impairment
A Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Moderate Renal Impairment and Normal Renal Function
This study is a single-center, non-randomized, open-label, parallel-group, multiple-dose Phase I clinical trial evaluating the pharmacokinetic characteristics of ammoxetine hydrochloride enteric-coated tablets in participants…
- Trial name
- NCT07694869
- Testing
- ammoxetine hydrochloride enteric-coated tablets
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Healthy
Bioavailability of BIBR 953 ZW in Healthy Subjects
To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with and without coadministration of 40 mg pantoprazole.
- Trial name
- NCT02170766
- Testing
- BIBR 1048 low1, BIBR 1048 low2, BIBR 1048 medium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bioequivalence
Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions
This bioequivalence study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of propafenone after a single oral dose administration under fasting…
- Trial name
- NCT03915340
- Testing
- Propafenone, Rytmonorm
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 50 mg Eplerenone Film-coated Tablets in Healthy Volunteers
This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Efez 50 mg eplerenone film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa", Ukraine) and…
- Trial name
- NCT05663372
- Testing
- Efez 50 mg eplerenone film-coated tablets, INSPRA® 50 mg eplerenone film-coated tablets
- Where
- Jordan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
1. Investigational Product 1. Imatinib mesylate tablet 400 mg 2. Glivec film-coated tablet 100 mg (Comparator) 2. Expected target disease 1. chronic myeloid leukemia 2. Gastrointestinal stromal tumors 3.
- Trial name
- NCT01751919
- Testing
- Imatinib mesylate tablet 400 mg, 1 Tablet, Glivec film-coated tablet 100 mg, 4 Tablets
- Where
- South Korea
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.