Day 1 - 6 40mg omeprazole QD; on Day 5 a single-dose of SOF/VEL with 250 mL of Coca Cola Classic is administered (test 1).

Day 8 - 13: 40mg omeprazole QD; on Day 12 a single-dose of SOF/VEL is administered (test 2).

Day 15 - 21: no treatment with omeprazole; on Day 19 a single-dose of SOF/VEL is administered (reference).

Hepatitis C

Swallowing Disorder

velpatasvir

Radboud university medical Center

Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.

Influence of the Acidic Beverage Cola on the Absorption of the HCV Agent Velpatasvir in Healthy Volunteers Being Treated With the Proton Pump Inhibitor Omeprazole.

Determination of velpatasvir AUC0-inf by noncompartmental analysis.
Descriptive statistics for the plasma concentrations of velpatasvir at each sampling time. Descriptive statistics for each PK parameter per treatment (geometric mean + CV%).
Geometric Mean Ratios and 90% confidence intervals of pharmacokinetic parameters of A (Test 1) vs. C (Reference) and of B (Test 2) vs. C (Reference).
AUC0-inf geometric mean ratios with a 90% Cl falling entirely within the range of 0.7 to 1.43 are considered bioequivalent.

To evaluate the safety and tolerability of SOFA/EL tablets in healthy volunteers.
Adverse events after administration of SOFA/EL in the three interventions will be described and compared (including clinically relevant laboratory abnormalities).

Determination of velpatasvir Cmax by noncompartmental analysis.

Determination of velpatasvir AUC0-48h by noncompartmental analysis.

Radboud University

An open-label, 3-period, single-centre, phase-I, multi PPI dose, single velpatasvir dose trial in 12 healthy volunteers.

Sjogren's Syndrome

National Institute of Dental And Craniofacial Research (NIDCR)

The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers

Basal and Stimulated Somatostatin Plasma Levels in Patients With Primary Sjogren's Syndrome and in Control Subjects

National Institute of Dental and Craniofacial Research (NIDCR)

The subject will be given vorikonazole twice a day for 5 days prior to the study. The dose will be 400 mg twice a day on day one ans 200 mg twice a day on days 2-5.

The subjects will be given placebo twice a day for 5 days prior to the study

Healthy

Placebo

Vorikonazole

Turku University Hospital

Effects of Voriconazole on the Pharmacokinetics and Pharmacodynamics of Oral Buprenorphine: A Two-phase Cross-over Study in Healthy Subjects

The psychomotor effects on buprenorphine will be assessed with the measurement of pupil size, Maddox wing test and digit symbol substitution test

The analgesic effect of buprenorphine will be evaluated using the cold pressor test. Briefly, the subject's hand is immersed into ice-cold water of + 4° C up to the wrist. The subject is told to keep his or her hand in the water and to report when the cold sensation becomes painful. Cold pain threshold is defined as the latency from the immersion of the hand to the subject's first report of pain. Cold pain intensity is assessed at 30 s intervals following immersion of the hand in cold water for up to 60s . A verbal numerical rating scale of 0-100 will be used.

Mari Fihlman

25 patients after elective colorectal surgery will be given 100 mg caffeine citrate orally diluted in 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

25 patients after elective colorectal surgery will be given 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.

Postoperative Ileus

Caffeine Citrate

Water

Ref 11. Mayo Clinic staff. Caffeine content for coffee, tea, soda and more. [Accessed March 14, 2017]

Hadassah Medical Organization

Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

The time in hours from end of surgery to first flatus.

The time in hours from end of surgery to first bowel movement.

The time in hours from end of surgery to first solid meal tolerated (the first time the patient is able to eat any food requiring chewing, without vomiting or going back to liquid diet)

The postoperative hospital stay is the number of hours from surgery until discharge. The criteria for hospital discharge include stable vital signs with no febrile morbidity for ≥24 hours, passage of stool, toleration of a solid diet and the absence of other complications.

After a baseline polysomnography (PSG), subject will receive 100 mg of trazodone 30 minutes prior to their 2nd PSG and will receive 100mg Placebo 30 minutes prior to their 3rd PSG.

After a baseline polysomnography (PSG), subject will receive 100 mg of placebo 30 minutes prior to their 2nd PSG and will receive 100mg trazodone 30 minutes prior to their 3rd PSG.

Sleep Bruxism

TMJ Pain

Chronic Pain

Sleep Disorder

BASELINE PSG Patient has to sleep over at the hospital (sleep lab). The technician will place several sensors on your scalp, temples, chest and legs to record all the data needed for your evaluation. You will be monitored throughout the duration of the test (approximately 6 hours). Brain waves, eye movements, chin muscle tone, breathing patterns, snoring, heart rate, blood pressure, blood oxygen level, body position and muscle activity will be recorded.

polysomnography

100 mg trazodone or placebo given once 30 minutes prior to 2nd PSG

Trazodone

placebo per os 30 minutes prior to 2nd PSG

Placebos

2nd psg, done 1 week after baseline. Patient has to sleep over at the hospital (sleep lab). The technician will place several sensors on your scalp, temples, chest and legs to record all the data needed for your evaluation. You will be monitored throughout the duration of the test (approximately 6 hours). Brain waves, eye movements, chin muscle tone, breathing patterns, snoring, heart rate, blood pressure, blood oxygen level, body position and muscle activity will be recorded.

100 mg trazodone per os 30 minutes prior to 3rd PSG

100 mg placebo per os 30 minutes prior to 3rd PSG

placebos

3rd PSG, done 2 weeks after baseline. Patient has to sleep over at the hospital (sleep lab). The technician will place several sensors on your scalp, temples, chest and legs to record all the data needed for your evaluation. You will be monitored throughout the duration of the test (approximately 6 hours). Brain waves, eye movements, chin muscle tone, breathing patterns, snoring, heart rate, blood pressure, blood oxygen level, body position and muscle activity will be recorded.

CHUM

Accuracy and Efficacy of Trazodone (Desyrel) on Sleep Quality and Pain Management of TMD Patient

Stabilisation de la qualité du Sommeil Chez le Sujet en Douleurs Orofaciales Chroniques - étude expérimentale en chassé croisé : Trazodone/ Placebo

Based on visual analysis of these parameters:
Sleep stage shifts: change from deeper to lighter sleep stage (stage 2, 3&4, REM toward stages 1 or 2); measured as number/hour.
Awakening: presence of alpha and beta electroencephalography (EEG) activities, with rise in submental/chin muscle tone, lasting>10s; measured as number/hour.
Movement arousal: an EEG pattern or awakening associated with major body movement; measured as number/hour.
Microarousal (MA): abrupt shift in EEG frequency lasting more than 3s and less than 10, excluding spindles and K-complexes; measured as number/hour.
Heart rate rapid fluctuations: acceleration of heart beat within 15s recorded by 2 electrodes at thoracic positions. Measured as number/hour.
Presence and severity of abnormal values will be determined based on AASM recommended cutoffs. For value reference in TMD women participants, see Dubrovksy et al 2014. We hypothesize all these parameters would decrease in Trazodone group.

Based on visual analysis of these parameters:
Sleep duration: from time in bed to wake as estimated by EEG (minutes) Sleep efficiency: % time asleep/time in bed (time in minutes) Sleep fragmentation: index of all above criteria (point 1) number/hour Sleep latency: from light off to first sign of sleep on EEG (minutes). REM sleep latency: from sleep onset (on EEG) to first REM sleep stage (minutes).
Presence and severity of abnormal values will be determined based on AASM recommended cutoffs. For references of values in TMD women participants, see Dubrovksy et al 2014. We hypothesize that sleep duration and efficiency will improve in Trazodone group, while sleep fragmentation, sleep latency, and REM sleep latency will decrease.

Measured with a numerical rating scale (0 to 10) were 0 is poorest possible sleep quality and 10 is the greatest possible sleep quality

Measured with a numerical rating scale (0 to 100) were 0 is no pain and 100 is the most intense pain imaginable.

cola/吐き気

Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.

The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers

Effects of Voriconazole on the Pharmacokinetics and Pharmacodynamics of Oral Buprenorphine: A Two-phase Cross-over Study in Healthy Subjects

Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

Accuracy and Efficacy of Trazodone (Desyrel) on Sleep Quality and Pain Management of TMD Patient

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