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NCT02447315
A Phase 1 Study to Investigate the Effect of Oral Doses of Pilocarpine on Salivary Secretion and Static Pupillometry in Healthy Subjects
Phase 1 trial testing Pilocarpine in Healthy Subjects in 12 participants. Completed in 1 June 2015.
1 June 2015
Quick facts
| Lead sponsor | Astellas Pharma Europe B.V. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 12 |
| Start date | 1 May 2015 |
| Primary completion | 1 June 2015 |
| Estimated completion | 1 June 2015 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Pilocarpine (PILOCARPINE) — full drug profile →
- Placebo
Conditions studied
- Healthy Subjects — all drugs for Healthy Subjects →
Sponsor
Astellas Pharma Europe B.V. — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Subjects. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pharmacodynamic parameter salivary secretion at specified time points
Time frame: Days 1-5
Measure (mg/min) salivary secretion at specific timepoints -
Pharmacodynamics assessed by area under the effect-time curve (AUE), saliva (AUEsal)
Time frame: Days 1-5 -
Pharmacodynamics assessed by maximal effect (Emax), saliva (Emax, sal)
Time frame: Days 1-5 -
Pharmacodynamics assessed by time at which the maximum salivary flow occurs (tmax, sal)
Time frame: Days 1-5
Sponsor's own description
The purpose of this study is to evaluate the pharmacodynamic effect of oral doses of pilocarpine on salivary secretion in healthy male and female subjects. In addition, pharmacodynamic effect on static pupillometry will be evaluated as well as pharmacokinetics and safety and tolerability of oral doses of pilocarpine in healthy subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02447315
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pilocarpine
Trials testing the same drug.
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- NCT04675151 — Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia · Phase 2 · completed
- NCT04005079 — Pilocarpine After Combined Cataract/Trabectome Surgery · Phase 3 · withdrawn
- NCT03460964 — Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study · NA · terminated
- NCT02935894 — Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat · NA · completed
Other recruiting trials for Healthy Subjects
Currently open trials in the same condition.
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Other Astellas Pharma Europe B.V. trials
Trials by the same sponsor.
- NCT03702777 — A Study of ASP8302 in Participants With Underactive Bladder · Phase 2 · completed
- NCT04742517 — A Study of MA-0217 (ASP1128) in Healthy Adult Subjects and Healthy Elderly Subjects · Phase 1 · completed
- NCT03282318 — A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Sub · Phase 2 · completed
- NCT03108755 — A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Sub · Phase 1 · completed
- NCT02788123 — A Study To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol) In Combination With Pantoprazole An · Phase 4 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02447315 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Europe B.V.
- Last refreshed: 10 August 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02447315.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing