ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- Healthy male and/or female subjects between the ages of 21 and 55 years
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- Baseline orthostatic hypotension defined as a ≥20 mm Hg reduction in systolic blood
pressure (SBP), a ≥10 mm Hg reduction in diastolic blood pressure (DBP) or the
development of significant postural symptoms (dizziness, lightheadedness, vertigo)
when going from the supine to standing position.
- Subjects who are currently prescribed and/or taking nitrates or nitric oxide donors in
any form on either a regular or intermittent basis.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Food Effect Study For New Formulation | |||
| Official Title ICMJE | An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study In Healthy Subjects Assessing The Pharmacokinetics And Safety Of Powder For Oral Suspension Of Sildenafil Citrate Administered Under Fasted And Fed Conditions | |||
| Brief Summary | The main objective of this study is to estimate the effect of food on sildenafil pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of sildenafil citrate. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
| Condition ICMJE | Healthy | |||
| Intervention ICMJE | Drug: sildenafil citrate
2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose | |||
| Study Arms ICMJE |
| |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 12 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | August 2012 | |||
| Actual Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 21 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Singapore | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01656798 | |||
| Other Study ID Numbers ICMJE | A1481313 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||