Who is sponsoring NCT02261090?

NCT02261090 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT02261090?

Interventions in NCT02261090: Formulation B: Pramipexole Slow release (SR) tablet, Formulation C: Pramipexole Slow release tablet, Formulation D: Pramipexole Slow release tablet, Formulation E: Pramipexole Slow release tablet, Formulation F: Pramipexole Slow release tablet, Formulation G: Pramipexole Slow release tablet, Formulation H: Pramipexole Slow release tablet, Pramipexole immediate release (IR) tablets.

Is NCT02261090 still recruiting?

NCT02261090 is currently completed. Last updated 9 October 2014.

Last reviewed 2014-10-09 · How we verify

NCT02261090

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multiple Dose Seven-way Cross-over Formulation-finding Study Comparing the Oral Bioavailability of Seven Prototype Slow-release Formulations With 0.75 mg Pramipexole (Four Days Each) to Immediate-release Tablets at Steady State in Healthy Male Volunteers

Completed Phase 1 Last updated 9 October 2014

What this trial tests

Phase 1 trial testing Formulation B: Pramipexole Slow release (SR) tablet in Healthy in 14 participants. Completed.

Timeline

1 June 2004

Primary endpoint
1 September 2004

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	1 June 2004
Primary completion	1 September 2004

Drugs / interventions tested

Formulation B: Pramipexole Slow release (SR) tablet
Formulation C: Pramipexole Slow release tablet
Formulation D: Pramipexole Slow release tablet
Formulation E: Pramipexole Slow release tablet — full drug profile →
Formulation F: Pramipexole Slow release tablet — full drug profile →
Formulation G: Pramipexole Slow release tablet — full drug profile →
Formulation H: Pramipexole Slow release tablet — full drug profile →
Pramipexole immediate release (IR) tablets — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 21 to 50, male only, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Plasma total exposure (AUCτ,ss)
Time frame: up to 168 hours after each drug administration
Urine total exposure (Aeτ,ss)
Time frame: up to 168 hours after each drug administration
Plasma maximum exposure (Cmax,ss)
Time frame: up to 168 hours after each drug administration
Plasma minimum exposure (Cmin,ss)
Time frame: up to 168 hours after each drug administration
Plasma average concentration (Cavg)
Time frame: up to 168 hours after each drug administration
Plasma peak to trough fluctuation (PTF)
Time frame: up to 168 hours after each drug administration

Sponsor's own description

Study to compare the oral bioavailability of seven prototype slow-release formulations to immediate-release tablets

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:

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02261090 (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 Boehringer Ingelheim
Last refreshed: 9 October 2014

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/NCT02261090.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing