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Healthy Subjects clinical trials

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NCT ID: NCT01953861 Completed - Healthy Subjects Clinical Trials

A Study to Evaluate Whether Food Has an Effect on the Uptake of Solifenacin and Tamsulosin When Administered in a Combination Tablet

Start date: April 2010
Phase: Phase 1
Study type: Interventional

To evaluate the effect of food (low and high fat breakfast vs. fasting) on the pharmacokinetics (what the body does to the drug) of a single dose of solifenacin and tamsulosin administered as combination tablet EC905. Also to evaluate the safety and tolerability of single doses of EC905 in young, healthy male subjects, when administered under fed (low and high fat) or fasting conditions.

NCT ID: NCT01953848 Completed - Healthy Subjects Clinical Trials

A Study to Evaluate How Tamsulosin (at 1 Dose) and Solifenacin (at 2 Different Doses) Are Taken up From the Intestine, Distributed Through the Body and Eliminated From the Body When Administered in Combination as a Single Tablet (Called EC905)

Start date: April 2010
Phase: Phase 1
Study type: Interventional

Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet frequently and often having a sudden urgent need to go to the toilet. Certain patients with an enlarged prostate have complaints that may benefit from a combination of tamsulosin and solifenacin. EC905 is a single tablet containing both tamsulosin and solifenacin. The current study aims at investigating how tamsulosin and solifenacin are taken up from the intestine, distributed through the body and eventually eliminated from the body when taken as a single EC905 tablet.

NCT ID: NCT01943487 Completed - Healthy Subjects Clinical Trials

A Study to Evaluate Whether Verapamil Has an Effect on the Uptake and Elimination of Solifenacin and Tamsulosin When Administered in a Combination Tablet

Start date: August 2009
Phase: Phase 1
Study type: Interventional

This study investigates the effect of the co-administration of verapamil on the steady-state pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet, EC905.

NCT ID: NCT01929577 Completed - Healthy Subjects Clinical Trials

A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation. This study will also evaluate the food effect on bioavailability of the test formulation, and evaluate the safety and tolerability after single-dose administration of the test- and reference-tablet formulations.

NCT ID: NCT01916863 Completed - Healthy Subjects Clinical Trials

Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the effect of LX4211 and the comparator drug canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy subjects in comparison to placebo.

NCT ID: NCT01913379 Completed - Healthy Subjects Clinical Trials

Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole

Start date: August 2011
Phase: Phase 1
Study type: Interventional

A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.

NCT ID: NCT01913184 Completed - Healthy Subjects Clinical Trials

Lung Bioavailability With Continuous or Discontinuous Nebulization

Start date: April 2012
Phase: N/A
Study type: Interventional

To compare the continuous and sicontinuous delivery of drug with AKITA.

NCT ID: NCT01911741 Completed - Healthy Subjects Clinical Trials

A Study to Compare Capsule and Tablet Forms of MDV3100 (Enzalutamide) After Administration of a Single Set Dose Under Fasted Conditions in Healthy Male Subjects

Start date: November 2012
Phase: Phase 1
Study type: Interventional

A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations. Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal.

NCT ID: NCT01911715 Completed - Healthy Subjects Clinical Trials

A Study to Explore the Routes of Elimination of MDV3100

Start date: April 2011
Phase: Phase 1
Study type: Interventional

A study to investigate the excretion routes of radio-labelled MDV3100.

NCT ID: NCT01901133 Completed - Healthy Subjects Clinical Trials

Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group

Start date: October 2011
Phase: Phase 1
Study type: Interventional

This study will assess the influence of hepatic impairment on the pharmacokinetics, safety and tolerability of a single dose of MDV3100 in male subjects. The study will consist of two treatment arms. Arm A will assess the influence of mild hepatic impairment, and Arm B will assess the influence of moderate hepatic impairment. Data obtained from subjects with hepatic impairment will be compared to data from Body Mass Index (BMI) and age-matched subjects with normal hepatic function.