N/A N=30 Correlation of Mesalamine Pharmacokinetics With Local Availability
Local Drug Concentration in Gastrointestinal Tract
Primary: The AUC of Mesalamine in Plasma — 40.8; 57.6; 36.8; 7.9 nM*h
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=48 Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment
Human Gastrointestinal Physiology Data
Primary: Average Duodenal Fluid pH in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen — 5.12; 5.36 pH
Phase 4 N=23 Concentration of Ertapenem in Colorectal Tissue
Diverticulosis, Colonic · Rectal Neoplasms · Colonic Neoplasms
Primary: Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..
Phase 1 N=25 Effect of Delivery Route on PK of Sufentanil NanoTab
Pharmacokinetics
Primary: AUC (0 - Inf) — 273.8; 212.5; 163.4; 24.9 h.pg/mL
Phase 1 N=40 Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
Plasma Concentrations
Primary: Cmax — 34.96; 249.55 pg/mL
Phase 4 N=12 Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Gastroparesis · Gastroesophageal Reflux Disease
Primary: Time to Maximal Omeprazole Concentration (Tmax) — 32; 97 minutes — p=< 0.01
N/A N=64 Effect of Inflammation on Pharmacokinetics of Posaconazole
Mycoses
Primary: C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L — 1.8; 23.5 mg/L — p=0.77
Phase 2 N=4 ACY-7 Oral Administration of Acyline
Healthy
Primary: Testosterone Blood Serum Concentration — 14.25; 8.53; 9.83; 9.83 ng/dl
Phase 1 N=12 Single Dose CHG Pharmacokinetic Study
Surgical Skin Preparation
Primary: Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. — 0; 0; 0 Participants
Phase 1 N=28 To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers
Common Cold
Primary: Mean Time to Onset of Gastric Emptying — 1.107; 8.534 minutes
Phase 4 N=5 Pharmacokinetics of Sublingual Versus Oral Tacrolimus in Patients Awaiting Kidney Transplantation
Kidney Failure, Chronic
Primary: C0 (ng/mL) — 1.45; 6.2; 1.25; 6.5 ng/mL
Phase 4 N=60 Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
Diabetes Mellitus, Type 2 · Obesity · Gastroparesis
Primary: Presence of RGV (Residual Gastric Volume) in Stomach — 7; 1 Participants
Phase 1 N=36 Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted
Healthy Subjects
Primary: Maximum Observed Plasma Concentration (Cmax) of Guaifenesin — 1066.11; 1117.31 ng/ml
Phase 4 N=17 Itraconazole Oral Absorption
Fungal Infection
Primary: AUC — 1624.8; 1365.5; 1282.2; 1848.7 ng*hr/mL
Phase 2 N=8 Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
Irritable Bowel Syndrome · Abdominal Pain · Colonic Diseases
Primary: T-max — 360; 180 minutes
Phase 2 N=268 A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy
Pain · Cancer · Colonic Diseases
Primary: Measurements of Visceral Pain, Using a 100-mm Visual Analog Scale (VAS) — 22.27; 18.93; 23.31; 22.22 mm — p=0.506
Phase 3 N=37 Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation
Chronic Idiopathic Constipation
Primary: Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically…
Phase 4 N=60 Pharmacokinetics of Preoperative Vancomycin
Surgical Site Infection · Vancomycin
Primary: Pharmacokinetics Analysis: V˅c — 2.56; 1.14 L
Phase 4 N=28 Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics
Gastrointestinal Mucosal Damage
Primary: Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule — 0.33; 1.48 Scores on a scale — p=<0.0001
Phase 1 N=11 A Comparison of the Bioavailability of OZ439 When Delivered Directly to the Small Intestine, or Via the Oral Route
Healthy Volunteers
Primary: OZ439 AUC0-∞ — 1230; 907; 398 ng*h/mL
Phase 2 N=32 PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
Colonic Neoplasms
Primary: Concentration of [6R]-5,10-methylene-THF in Tumor Tissue — 1871; 959; 4725; 2393 pmol/g — p=0.0323
Phase 1 N=18 Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
Epilepsy
Primary: Cmax - the Maximum Plasma Concentration — 18048; 16007; 17042 ng/mL
Early Phase 1 N=7 Pharmacokinetics of Metronidazole Dermal Products
Bioequivalence
Primary: PK Parameters — 283; 341; 189 ng*h/mL
Phase 4 N=75 Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
Fungal Infection · Acute Myelogenous Leukemia · Neutropenia
Primary: Mean POS Plasma Concentrations on Days 2, 3, and 8. — 230; 346; 637 ng/mL
Phase 1 N=28 Bioequivalence Study of Colchicine Tablets
Healthy
Primary: Maximal Plasma Concentration (Cmax) — 2,503.04; 2,496.88; 1,706.03 pg/mL
Phase 1 N=48 Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
Healthy
Primary: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72) — 248; 251; 266; 264 nmol*h/L
Phase 4 N=25 Cimetidine Biowaivers
Healthy
Primary: AUC — 3896; 3661; 3495; 3512 ng*hr/ml
Phase 1 N=30 Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions
Healthy
Primary: Cmax = Maximum Observed Concentration. — 295; 256 ng/mL
Phase 4 N=96 Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants
Meconium Ileus · Very Low Birth Weight Infant
Primary: Time to Complete Meconium Evacuation in Days — 7; 8 days of life — p=0.61
Phase 1 N=24 Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution
Asthma
Primary: Area Under the Plasma Concentration-time Profile From Time 0 the Last Quantifiable Concentration (AUC0-last) With Dose Normalization — 658; 700; 716; 748 pg.h/mL…