ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01154218
Conditions: Healthy
Keywords: bioequivalence food effect pharmacokinetics crizotinib
Sponsor: Pfizer
Start date: 2010-08-01; Completion date: 2010-11-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC relative to Powder in Capsule (PIC) of crizotinib, and lack of an effect of high fat meal on the pharmacokinetics (PK) of crizotinib when administered as CIC Formulation in healthy volunteers.

Detailed description:
The purpose of this study is to demonstrate bioequivalence of the CIC relative to IRT and CIC relative to PIC, and lack of an effect of food on the PK of crizotinib in healthy volunteers.

Arms: arm 1: All subjects will receive four treatments in one of the indicated orders:

A-B-C-D, B-D-A-C, C-A-D-B, D-C-B-A
Interventions: intervention 1: crizotinib
Intervention descriptions: intervention 1: Treatment A (Reference 1): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg IRT and 2 × 100-mg IRTs.

Treatment B (Reference 2): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg PIC and 2 × 100 mg PICs.

Treatment C (Test for BE, Reference for Food Effect): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 250-mg CIC.

Treatment D (Test High Fat): a 250 mg single dose of crizotinib administered with a high-fat meal as 1 × 250-mg CIC

Protocol documents:
Clinical trial NCT01163721
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus T2DM Ranolazine Ranexa HbA1c
Sponsor: Gilead Sciences
Start date: 2010-06-01; Completion date: 2010-11-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM) despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have benefited from additional control of blood glucose levels. The study assessed the metabolic effects of ranolazine, including its effect in lowering glycosylated hemoglobin A1c (HbA1c), and lowering glucose while fasting, and following a meal (postprandial).

Participants were randomized in a 1:1 ratio to receive ranolazine or placebo, and were stratified by HbA1c ≤ 7.5% or \> 7.5%. Enrollment was to include no more than two-thirds of participants with baseline HbA1c ≤ 7.5%. Other than glucose values, efficacy endpoint results remained blinded during the study; for safety purposes, the investigator was to be alerted of severe hyperglycemia or hypoglycemia.

Participants were instructed to maintain logs of their physical activity/exercise (Subject Activity Assessment) and study drug dosing (Dosing Log).

Detailed description:

Arms: arm 1: Participants were randomized to receive ranolazine for 12 weeks. arm 2: Participants were randomized to receive placebo to match ranolazine for 12 weeks.
Interventions: intervention 1: Ranolazine intervention 2: Placebo
Intervention descriptions: intervention 1: Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily intervention 2: Placebo to match ranolazine administered orally twice daily

Protocol documents:
Clinical trial NCT01168687
Conditions: Alcohol Abuse Drug Abuse
Keywords: keppra levetiracetam alcoholism genetics subjective report
Sponsor: University of California, San Francisco
Start date: 2008-11-01; Completion date: 2010-11-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The overall goals of this study are to (1) expand knowledge about interactions of levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to measure postural control (which has been used as a marker of intoxication) and the effects of levetiracetam on postural control.

Detailed description:
The investigators propose a 42-day, double-blind, placebo-controlled crossover study in light to moderate and heavy alcohol users who are social drinkers.

The specific aims are to:

1. Determine if levetiracetam alters daily alcohol consumption by comparing the mean drinks consumed per day during levetiracetam administration compared with the mean drinks per day consumed during placebo administration.
2. Obtain blood that will be banked for future genetic analysis of polymorphisms in genes that may predict the level of response to alcohol or effects of levetiracetam on alcohol consumption.
3. Test whether the AccuswayTM platform can detect changes in body sway in light to moderate or heavy social drinkers and in subjects taking levetiracetam versus placebo.

Arms: arm 1: Twenty moderate to heavy social alcohol users will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days. arm 2: Twenty moderate to heavy social alcohol users will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.
Interventions: intervention 1: Levetiracetam (Keppra) intervention 2: Placebo
Intervention descriptions: intervention 1: Group A: Twenty moderate to heavy social alcohol users will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days.

Group B: Twenty moderate to heavy social alcohol users will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days. intervention 2: None

Protocol documents:
Clinical trial NCT01169038
Conditions: Pulmonary Sarcoidosis Lung Function
Keywords: sarcoidosis mycobacteria lung pulmonary radiographic improvement
Sponsor: Vanderbilt University
Start date: 2010-07-01; Completion date: 2010-11-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Sarcoidosis is a granulomatous disease for which the molecular and immunologic association with mycobacteria continues to strengthen. The investigators are interested in conducting a proof-of-concept investigation of the effects of antibiotics on sarcoidosis resolution. The investigators hypothesize that pulmonary sarcoidosis will improve faster if patients are given antimycobacterial therapy, in addition to their standard therapy.

Detailed description:

Arms: arm 1: Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD

\*\*Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. \*\*We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway.
Interventions: intervention 1: levaquin; ethambutol; rifampin and azithromycin.
Intervention descriptions: intervention 1: Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD

\*\*Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. \*\*We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway.

Protocol documents:
Clinical trial NCT01175473
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2010-08-01; Completion date: 2010-11-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010), in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks of treatment.

The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide, in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose concentration curve (AUC) after a standardized breakfast at Week 4.

The secondary objectives are to assess the effects of lixisenatide on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast, 24-hour profile of plasma glucose, glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY \[PYY3-36\] and oxyntomodulin); and to assess the clinical and laboratory safety profile.

Detailed description:
The duration of the study for each patient is up to 7 weeks including a screening period up to 2 weeks, a treatment period of 4 weeks (Day 1 to Day 28), and an end-of-study visit 7 +/- 2 days after last study drug administration.

Arms: arm 1: 1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 2 weeks, followed by 20 mcg QD for up to Week 4. arm 2: 2-step initiation regimen of liraglutide: 0.6 milligram (mg) QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Pen auto-injector intervention 3: Liraglutide intervention 4: Pre-filled pen injector intervention 5: Metformin
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily 30 minutes before breakfast. intervention 2: None intervention 3: Self administered by subcutaneous injections once daily 30 minutes before breakfast. intervention 4: None intervention 5: Metformin to be continued at stable dose (1.5 gram per day) up to Week 4.

Protocol documents:
Clinical trial NCT01181011
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2010-08-01; Completion date: 2010-11-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects.

To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and in combination, in healthy Chinese subjects.

To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy Chinese subjects.

Detailed description:

Arms: arm 1: all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order
Interventions: intervention 1: amlodipine/telmisartan/combination
Intervention descriptions: intervention 1: patient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval.

Protocol documents:
Clinical trial NCT01189201
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2010-08-01; Completion date: 2010-11-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of the current study is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test) compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference), both in the fasting state. All 42 subjects entered are planned to be included in this comparison.

The secondary objective is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet after administration of a standardised high fat, high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the 42 subjects entered 18 subjects are planned to be included in this comparison.

An additional objective is to investigate the relative bioavailability of a second formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned to be included in this comparison.

Detailed description:

Arms: arm 1: medium single dose ofBI 10773/linagliptin FDC (Formulation A1) arm 2: medium single dose of mono components BI 10773/linagliptin arm 3: medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal arm 4: medium single dose of BI 10773/linagliptin FDC (Formulation A3)
Interventions: intervention 1: BI 10773/linagliptin intervention 2: BI 10773/linagliptin intervention 3: BI 10773/linagliptin SID intervention 4: BI 10773/linagliptin FDC
Intervention descriptions: intervention 1: medium single dose of BI 10773/linagliptin FDC (Formulation A1) intervention 2: medium single dose of BI 10773/linagliptin FDC (Formulation A3) intervention 3: medium single dose of mono components BI 10773/linagliptin intervention 4: medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal

Protocol documents:
Clinical trial NCT01189604
Conditions: Gastrointestinal Endoscopy Gastrointestinal Polypectomy
Keywords: propofol endoscopy sedation
Sponsor: AstraZeneca
Start date: 2010-08-01; Completion date: 2010-11-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
Interventions: intervention 1: Placebo intervention 2: ICI35,868 (propofol) intervention 3: ICI35,868 (propofol) intervention 4: ICI35,868 (propofol) intervention 5: ICI35,868 (propofol) intervention 6: ICI35,868 (propofol) intervention 7: ICI35,868 (propofol)
Intervention descriptions: intervention 1: Infusion of placebo, same infusion rates as for arm 2 intervention 2: Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute intervention 3: Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute intervention 4: Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute intervention 5: Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute intervention 6: Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute intervention 7: Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute

Protocol documents:
Clinical trial NCT01190514
Conditions: Depression - Major Depressive Disorder
Keywords: DVS SR healthy Bioequivalence study
Sponsor: Pfizer
Start date: 2010-09-01; Completion date: 2010-11-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.

To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg SR formulation of DVS.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: desvenlafaxine succinate sustained release intervention 2: desvenlafaxine succinate sustained release intervention 3: desvenlafaxine succinate sustained release intervention 4: desvenlafaxine succinate sustained release
Intervention descriptions: intervention 1: Two tablets of 25 mg, single administration, under fed condition intervention 2: One tablet of 50 mg, single administration, under fed condition intervention 3: Two tablets of 25 mg, single administration, under fast condition intervention 4: One tablet of 50 mg, single administration, under fast condition

Protocol documents:
Clinical trial NCT01195675
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2010-08-01; Completion date: 2010-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo

Detailed description:

Arms: arm 1: single oral (high and low) dose per subject arm 2: 2 single oral doses per subject arm 3: single oral dose per subject
Interventions: intervention 1: BI 10773 (low) intervention 2: Moxifloxacin intervention 3: BI 10773 Placebo intervention 4: BI 10773 (high)
Intervention descriptions: intervention 1: single oral dose intervention 2: single oral dose intervention 3: 2 times single dose intervention 4: single oral dose

Protocol documents:
Clinical trial NCT01204853
Conditions: Hypertension, Pulmonary
Keywords: sitaxentan sodium hypertension
Sponsor: Pfizer
Start date: 2010-08-01; Completion date: 2010-11-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sitaxentan
Intervention descriptions: intervention 1: sitaxentan sodium 100 mg

Protocol documents:
Clinical trial NCT01208961
Conditions: Severe Hypertriglyceridemia
Keywords: Eicosapentaenoic Acid Docosahexaenoic Acid Hypertriglyceridemia Omega-3 acid ethyl esters Omega-3 carboxylic acids Epanova Lovaza bioavailability pharmacokinetics low-fat meal high-fat meal
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2010-11-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Epanova (4 g) and Lovaza (4 g) intervention 2: Lovaza (4 g) and Epanova (4 g)
Intervention descriptions: intervention 1: Single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals intervention 2: Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose ofEpanova (omefas),4x1g capsules, taken with high-fat meals

Protocol documents:
Clinical trial NCT01259128
Conditions: Nocturia
Sponsor: Serenity Pharmaceuticals, Inc.
Start date: 2010-04-01; Completion date: 2010-11-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Detailed description:
Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

Arms: arm 1: SER120 Level 1 (500 ng/day) arm 2: SER120 Level 2 (750 ng/day)
Interventions: intervention 1: SER120 Nasal Spray 500 ng/day intervention 2: SER120 nasal spray 750 ng/day
Intervention descriptions: intervention 1: SER120 Level 1 intervention 2: SER120 (750 ng/day)

Protocol documents:
Clinical trial NCT01304316
Conditions: Anesthesia
Sponsor: St. Renatus, LLC
Start date: 2010-09-01; Completion date: 2010-11-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline

Detailed description:
The purpose of this study was to determine the safety and pharmacokinetics of the standard dose of intranasal Kovacaine Mist of 0.6 mL (18 mg tetracaine HCl with 0.3 mg oxymetazoline HCl) and a proposed maximum recommended dental dose of 1.2 mL (36 mg tetracaine HCl with 0.6 mg oxymetazoline HCl). The primary objectives were to determine if either dose significantly changed blood pressure readings (systolic and diastolic), pulse rate, or oxygen saturation levels from baseline pretreatment values and to determine the safety profile of both doses. The secondary objectives were to establish the pharmacokinetics of oxymetazoline, tetracaine, and its major metabolite (parabutylaminobenzoic acid) following the intranasal administration of both doses. Each subject received the standard dose (3 sprays in each nostril with 4 minutes between each pair of sprays) followed 1 to 3 weeks later by the high dose (as 6 sprays in each nostril).

Arms: arm 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
Interventions: intervention 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Intervention descriptions: intervention 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Protocol documents: