NCT02260024 is a Phase 1 clinical trial of High fat, high caloric meal in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT02260024?

NCT02260024 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT02260024?

Interventions in NCT02260024: High fat, high caloric meal, Pramipexole IR tablets, Pramipexole SR C, Pramipexole SR C2, Pramipexole SR C2A, Pramipexole SR C2B.

Is NCT02260024 still recruiting?

NCT02260024 is currently completed. Last updated 7 October 2014.

Last reviewed 2014-10-07 · How we verify

NCT02260024

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

A Single Dose Five-way Cross-over Study to Establish an in Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets With 0.375 mg Pramipexole in Healthy Male Volunteers

Completed Phase 1 Last updated 7 October 2014

What this trial tests

Phase 1 trial testing High fat, high caloric meal in Healthy in 15 participants. Completed.

Timeline

1 October 2005

Primary endpoint
1 December 2005

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 October 2005
Primary completion	1 December 2005

Drugs / interventions tested

High fat, high caloric meal
Pramipexole IR tablets — full drug profile →
Pramipexole SR C — full drug profile →
Pramipexole SR C2 — full drug profile →
Pramipexole SR C2A — full drug profile →
Pramipexole SR C2B — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 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.

AUC0-30 (area under the concentration time curve of pramipexole in blood plasma over the time interval 0 to 30 h after drug administration)
Time frame: Up to 30 hours after drug administration
Cmax (maximum measured concentration of pramipexole in blood plasma)
Time frame: Up to 30 hours after drug administration

Sponsor's own description

The primary objective of the study was to estimate the magnitude of the error in the prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data applying the methods of IVIVC. The secondary objective of the study was to investigate whether the intake of food 30 minutes prior to drug administration affects the systemic exposure of pramipexole SR C2 or not

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Comparative Pharmacokinetics and Bioequivalence Evaluation of Two Formulations of Pramipexole Dihydrochloride Extended-Release Tablets in Healthy Chinese Subjects Under Fasted and Fed States: A Randomized, Open-Label, Single-Dose, Two-Period Crossover Clinical Trial.
Yang L, Zhang L, Luo Z. · · 2023 · PMID 37600497 · DOI 10.2147/dddt.s421449

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

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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 NCT02260024 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 7 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/NCT02260024.

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