- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00469053
Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID: 855509)
Multiple Dose Bioequivalence Trial Comparing a Down-Scaled New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch (Protocol ID: 855509)
Panoramica dello studio
Descrizione dettagliata
Main: To demonstrate the bioequivalence of the new transdermal patch versus the current transdermal patch (Reference) after multiple patch application. Pharmacokinetic target parameters are AUCss, and Css,max.
Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications. To evaluate the following further Pharmacokinetic parameters: Css,min, Css,ave, PTF, Swing, tss,max, and t1/2,z
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Mannheim, Germania
- Site Mannheim
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male Caucasian subjects, aged 18-55 years
- BMI between 18 and 30 kg/m2 inclusive, with a lower limit of body weight of 50 kg
- Subjects must be in good health as determined by medical history, physical examination, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters.
- Subjects giving written informed consent to participate within this trial.
Exclusion Criteria:
- Resting pulse rate < 45 or > 100 beats / min
- Resting blood pressure:
systolic blood pressure < 90 and > 160 mmHg, diastolic blood pressure < 40 and > 100 mmHg
- History or presence of orthostatic hypotension
- Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies, HCV antibodies
- Participation in another clinical trial in the last 30 days before starting this trial (i.e., first administration of IMP)
- Positive drug of abuse screening
- Diseases or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Marked repolarisation abnormality (e.g., suspicious or definite congenital long QT syndrome with QT/QTc>500msec or prolonged QTc, i.e.>450msec) or co- medication that is known to influence cardiac repolarisation substantially
- Bronchial asthma
- Definite or suspected history of drug allergy or hypersensitivity
- Subjects who have received any prescribed and non-prescribed systemic or topical medication like analgesics, NSAIDs (except standard dose of a NSAID once a week for the treatment of headache), hypnotics, sedatives, narcotics, neuroleptics or other medications that may lower the seizure threshold, MAO-inhibitors, serotonin-reuptake-inhibitors, tricyclic antidepressants, other centrally acting substances and substances which are known to interact with the drug metabolizing enzymes (e.g., inhibitors or inducers of CYP3A4 or CYP2D6) four weeks prior to the start of the trial (i.e. first administration of IMP). Each case has to be decided upon individually by the investigator after consultation with the Sponsor.
- Evidence of alcohol or drug abuse
- Not able to abstain from consumption of:
Caffeine containing beverages or food (tea, coffee, cola, chocolate, etc.) Quinine containing beverages or food (bitter lemon, tonic water) Grapefruit juice (sweet, sour) Poppy seeds containing beverages or food;
- Blood loss (> 100 mL) due to e.g. blood donation within 3 months before starting this trial (i.e., first administration of IMP)
- History of seizures or at risk (i.e. head trauma, epilepsy in family anamnesis, unclear loss of consciousness)
- Known or suspected of not being able to comply with the trial protocol
- Not able to communicate meaningfully with the investigator and staff
- Smoking of >10 cigarettes/day or equivalent
Trial specific exclusion criteria:
- Subjects not able to abstain from strenuous exercise during the whole course of the trial
- Abnormality (e.g. scar, tattoo) or unhealthy skin at application site according to examination by the investigator
- Existing chronic skin disease or history of skin disease at the application site within the last 4 weeks
- Presence of one of the contraindications as detailed in the current protocol
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Wolfgang Timmer, Dr., CRS Clinical Research Services Mannheim
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 855509
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .