Pharmacokinetic Interaction Between Ibuprofen and Acetaminophen Oral Suspension
22 juni 2022 uppdaterad av: Laboratorios Silanes S.A. de C.V.
Study of no Pharmacokinetic Interaction Between Ibuprofen 100 mg and Acetaminophen 125 mg, Suspension Administered Individually or in Combination, Single Dose in Healthy Subjects, Both Genders Under Fasting Conditions
This study was carried out in the Clinical and Analytical Unit of the Pharmacology and Toxicology Department of the Faculty of Medicine of the Autonomous University of Nuevo León, in order to compare the bioavailability (Cmax, AUC) of an oral formulation containing Ibuprofen 100 mg/Acetaminophen 125 mg in combination with the two oral formulations Ibuprofen 100 mg or Acetaminophen 125 mg administered as a single dose, in healthy subjects under fasting conditions.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
The study design was crossover, 3 x 6 x 3, open, prospective and longitudinal, at a single dose, of the combination of Ibuprofen 100 mg/Acetaminophen 125 mg/5 mL suspension, administered orally versus each component administered individually Ibuprofen 100 mg/5 mL or Acetaminophen 125 mg/3.9 mL, with an elimitation period (washout) of 1 week.
In order to compare the pharmacokinetic profile (Cmax and AUC0-t) of the Ibuprofen/Acetaminophen combination 100 mg/125 mg/5 mL, versus each component administered individually, in 42 healthy subjects, of both genders, under fasting conditions, to establish the interaction of drugs in combination.
As well as, to characterize the pharmacokinetic parameters, Cmax and AUC0-t, AUC0-∞, Tmax, Ke, and T1/2 and to establish the frequency and type of adverse events with the two formulations.
Studietyp
Interventionell
Inskrivning (Faktisk)
42
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Mexico City, Mexiko, 11000
- Laboratorio Silanes, S.A. de C.V.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- The subjects must have been accepted by the COFEPRIS research subjects registration database.
- Subjects without a subordinate relationship with the researchers.
- Subjects who have given informed consent in writing.
- Subjects of both genders, aged between 18 and 55 years, Mexicans. - -Subjects with no background of hypersensitivity or allergies to the drug under study or related drugs.
- Body mass index between 18 and 27 kg/m2.
- Healthy subjects, according to the results of the complete clinical history, electrocardiogram and the integration of the results of the clinical analyses, carried out in certified clinical laboratories, without alterations that require a medical intervention as a consequence.
- Subjects with negative results for immunological tests (Anti-HIV, Anti-hepatitis B and C, VDRL).
- Subjects with negative results in drug abuse screening tests: tetrahydrocannabinoids, cocaine and amphetamines.
- Negative (qualitative) pregnancy test for women of childbearing potential without Bilateral tubal obstruction or hysterectomy.
- In the case of women of childbearing age, they must have a birth control method, including barrier methods, non-hormonal intrauterine device, or bilateral tubal obstruction.
Exclusion Criteria:
- Subjects with recent history or physical examination evidence of gastrointestinal, renal, hepatic, endocrine, respiratory, cardiovascular, dermatological, or hematological disease that could affect the pharmacokinetic study of the product in research.
- Subjects who have been exposed to drugs known as liver enzyme inducers or inhibitors or who have taken drugs potentially toxic within 30 days before the start of the study.
- Subjects who have received any medication during the 7 days before the start of the study.
- Subjects who have been hospitalized for any problem during the three months before the start of the study.
- Subjects who have been rejected by the registry database of research subjects of COFEPRIS, for having participated in a clinical study within the three months prior to the start of the study.
- Subjects who have received investigational drugs within the previous 60 days th the start of the study.
- Subjects allergic to the study drug or related drugs.
- Subjects who have ingested alcohol or drinks containing xanthines (coffee, tea, cocoa, chocolate, cola) or who have eaten charcoal-grilled food or grapefruit juice , at least 10 hours before the start of the study or who have smoked tobacco 24 hours before to the start of the internment period.
- Subjects who have donated or lost 450 mL or more of blood within the previous 60 days of the beginning of the study. - Subjects with a history of drug and/or alcohol abuse according to the DSM-IV-TR Criteria.
- Research subjects who presents alterations in the vital signs recorded during the selection.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Group A: Ibuprofen/ Acetaminophen oral suspension in fixed dose
Pharmaceutical Form: Oral Suspension Formula: Ibuprofen 100 mg/ Acetaminophen 125 mg/ 5 mL Dosage: 5 mL Administration way: oral
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Formula : 100 mg/ 125 mg /5mL Pharmaceutical Form: Oral suspension Dosage: 5mL (100 mg/125mg) Administration way: oral
Andra namn:
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Aktiv komparator: Group B: Ibuprofen oral suspension
Pharmaceutical Form: Oral Suspension Formula: Ibuprofen 2 g/100 mL Dosage: 5 mL (100 mg of ibuprofen) Administration way: oral
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Pharmaceutical Form: oral suspension Formula: 2 g/100 mL Dosage: 5 mL(100 mg of Ibuprofen) Administration way: oral
Andra namn:
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Aktiv komparator: Group C: Acetaminophen oral suspension
Pharmaceutical Form: Oral Suspension Formula: Acetaminophen 3.2 g/100 mL Dosage: 3.9 mL (125 mg of acetaminophen) Administration way: oral
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Pharmaceutical Form: oral suspension Formula: 3.2 g/100 mL Dosage: 3.9 mL (125 mg) Administration way: oral
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Maximum observed concentration following the treatment (Cmax)
Tidsram: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Evaluate the pharmacokinetics profile of the fixed dose Ibuprofen/Acetaminophen oral suspension, employing the maximum observed concentration following the treatment (Cmax), obtained graphically, from the plasma concentration profile with respect to time.
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Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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The area under the curve from time zero to the last measurable concentration (AUC 0-t)
Tidsram: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Evaluate the fixed dose pharmacokinetics profile of Ibuprofen/Acetaminophen oral suspension, employing the area under the curve from time zero to the last measurable concentration (AUC 0-t) using the linear trapezoidal method.
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Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Frekvens av förekomst av biverkningar
Tidsram: 1, 8 och 16 dagar
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Procentandelen av frekvensen för varje biverkning utvärderades.
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1, 8 och 16 dagar
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The area under the curve from time zero to infinity calculated (AUC 0-inf)
Tidsram: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Evaluate the fixed dose pharmacokinetics profile of ibuprofen/Acetaminophen oral suspension, employing the area under the curve from time zero to infinity calculated (AUC 0-inf)
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Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Time of the maximum measured concentration (Tmax)
Tidsram: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Evaluate the fixed dose pharmacokinetics profile of ibuprofen/Acetaminophen oral suspension, employing time of the maximum measured concentration Tmax), obtained graphically, from the plasma concentration profile with respect to time.
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Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Elimination rate (Ke)
Tidsram: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Evaluate the fixed dose pharmacokinetics profile of ibuprofen/Acetaminophen oral suspension, employing the elimination rate (Ke), estimated from the terminal linear portion of the plasma concentration profile with respect to time (on a semi-log scale)
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Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Half time elimination (T1/2)
Tidsram: Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Evaluate the pharmacokinetics profile of the fixed dose ibuprofen/Acetaminophen oral suspension, employing the half time elimination (T1/2) by the quotient of Ln(2)Ke.
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Baseline, 0.16, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12,0 and 14.0 hours.
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Adverse events
Tidsram: 1, 8 and 16 days
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Any adverse event was classified by severity, treatment and its relationship with the study drug evaluated.
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1, 8 and 16 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Lourdes Garza Ocaña, M.D, Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
- Tanner T, Aspley S, Munn A, Thomas T. The pharmacokinetic profile of a novel fixed-dose combination tablet of ibuprofen and paracetamol. BMC Clin Pharmacol. 2010 Jul 5;10:10. doi: 10.1186/1472-6904-10-10.
- Zhang Y, Mehrotra N, Budha NR, Christensen ML, Meibohm B. A tandem mass spectrometry assay for the simultaneous determination of acetaminophen, caffeine, phenytoin, ranitidine, and theophylline in small volume pediatric plasma specimens. Clin Chim Acta. 2008 Dec;398(1-2):105-12. doi: 10.1016/j.cca.2008.08.023. Epub 2008 Sep 3.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 februari 2019
Primärt slutförande (Faktisk)
8 mars 2019
Avslutad studie (Faktisk)
1 maj 2019
Studieregistreringsdatum
Först inskickad
16 juni 2022
Först inskickad som uppfyllde QC-kriterierna
16 juni 2022
Första postat (Faktisk)
23 juni 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juni 2022
Senast verifierad
1 juni 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Agenter från det perifera nervsystemet
- Enzyminhibitorer
- Analgetika
- Sensoriska systemagenter
- Antiinflammatoriska medel, icke-steroida
- Analgetika, icke-narkotiska
- Antiinflammatoriska medel
- Antireumatiska medel
- Cyklooxygenashämmare
- Antipyretika
- Paracetamol
- Ibuprofen
Andra studie-ID-nummer
- BD IP-Sil No. 102-18
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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