- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01800227
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fasting Conditions
An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of FDC of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Actoplus Met® 15 mg/850 mg Tablets (Reference Formulation, Takeda Pharmaceuticals America Inc., USA) in Healthy Human Volunteers Under Fasting Conditions.
Objective:
subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days.
Study Design:
Randomized, Two-Way Crossover, Single-Dose, and Open-Label
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Gujarat
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Village Bhat, Gandhinagar, Gujarat, India
- Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
The volunteers were included in the study based on the following criteria:
- Sex: male.
- Age: 18 - 45 years.
- Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- Healthy and willing to participate in the study.
- Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
- Non-smokers or smoker who smokes less than 10 cigarettes per day
Exclusion Criteria:
The volunteers were excluded from the study based on the following criteria:
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal ECG or Chest X-ray.
- Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P.
- Respiratory rate less than 12/minute or more than 20/minute
- History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- History of alcohol or drug abuse
- Positive breath alcohol test
- Recent history of kidney or liver dysfunction.
- History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
- Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- History of heart failure.
- HIV, HCV, HBsAg positive volunteers.
- Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines,Cocaine positive volunteers based on urine test.
- Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
- Administration of any study drug in the period 0 to 3 months before entry to the study.
- History of significant blood loss due to any reason, including blood donation in the past 3 months.
- History of pre-existing bleeding disorder.
- Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
- Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Piano di studio
Come è strutturato lo studio?
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
bioequivalenza basata su Composite of Pharmacokinetics
Lasso di tempo: Pre-dose e 0,25, 0,5, 1,0, 1,5, 2,0, 2,5, 3,0, 4,0, 6,0, 8,0, 12,0, 14,0, 15,0, 16,0, 17,0, 18,0, 20,0, 24,0, 36,0, 48,0, 72,0, 96,0, 120,0 ore dopo la somministrazione della dose.
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bioequivalenza; L'intervallo di confidenza geometrica al 90% del rapporto delle medie dei minimi quadrati del test rispetto al prodotto di riferimento deve essere compreso tra 80,00% e 125,00% per AUC-unf, AUCo-t e Cmax.
|
Pre-dose e 0,25, 0,5, 1,0, 1,5, 2,0, 2,5, 3,0, 4,0, 6,0, 8,0, 12,0, 14,0, 15,0, 16,0, 17,0, 18,0, 20,0, 24,0, 36,0, 48,0, 72,0, 96,0, 120,0 ore dopo la somministrazione della dose.
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Completamento primario (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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PK-09-181
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 .