Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02688387

A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects

Hypertension, Pulmonary Clinical Trial

Official title:
A Phase 1 Study to Demonstrate the Relative Bioavailability of Fixed Dose Combinations of Ambrisentan and Tadalafil in Healthy Subjects

Clinical Trial Summary

This study is designed to understand the relative bioavailability (proportion of the administered dose that is absorbed into the bloodstream) of several fixed dose combinations (FDCs) tablets of ambrisentan and tadalafil for further development and to provide pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence (BE - the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability) study. Depending on formulation work, the study will allow up to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies. The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted state. This is a single centre, Phase 1, single dose, randomised, open label crossover study with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects. Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram [mg] + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are identified in this part of the study, then they will be re-formulated and tested in part 2. If no successful formulations are identified in part 1 of the study, then part 2 will be utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less, are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess food effect and part 3 will not be required. If successful formulations are identified in this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not already assessed in this part. Therefore, part 3 is optional and utility is dependent on the results of the previous study parts.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02688387
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date March 18, 2016
Completion date August 4, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT04095286 - Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants Phase 1
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Completed NCT02191137 - Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION) Phase 4
Completed NCT01959828 - Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery Phase 3
Withdrawn NCT01202045 - Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients N/A
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT01121458 - Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed Phase 4
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1
Terminated NCT00825266 - Insulin Resistance in Pulmonary Arterial Hypertension Phase 4
Terminated NCT00384865 - A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension Phase 2
Active, not recruiting NCT03926572 - Acute Decompensation of Pulmonary Hypertension N/A
Completed NCT02826252 - Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20) N/A
Completed NCT02545465 - A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice N/A
Recruiting NCT04498299 - Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness
Recruiting NCT02558582 - Effect of Exercise Training in Patients With Pulmonary Hypertension N/A
Active, not recruiting NCT02562235 - Riociguat in Children With Pulmonary Arterial Hypertension (PAH) Phase 3
Completed NCT02755298 - Chronic Clinical Effect of Acetazolamide Phase 2/Phase 3
Completed NCT02576002 - Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension) N/A
Terminated NCT03043976 - Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension N/A
Completed NCT01178073 - A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) Phase 3