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Part Used : น้ำจากผลActivity : EFFECTS ON PHARMACOKINETICSolvent/Active Compound : orange juice and calcium-fortified orange juiceType of experiment : humanType of animal : -Type of study : Open trialN(Total) : 15* (M/F = 8/7)N(Treatment) : 15 (M/F = 8/7)Sex : Both sexAge : >/= 18 yrs. (mean 38.8 +/- 8.1)Route : Oral administrationDose/Conc.(herb) : A single 500 mg tablet of ciprofloxacin with 12 ounces of orange juice or orange juice fortified with calcium.Duration : Blood samples were collected predose (baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours after each ciprofloxacin administration.Type of interaction : PharmacokineticsInteraction with drug : CiprofloxacinDose/Conc.(drug) : A single 500 mg tablet of ciprofloxacinResult : PositiveRemark : Result: When the two orange juice arms were compared to each other, Cmax and AUC24 were decreased by 22% (p = 0.005) and 21% (p = 0.015) when ciprofloxacin was taken with calcium-fortified orange juice as compared to the nonfortified version.Note : Although ciprofloxacin is marginally bioequivalent when administered with orange juice, it is not when it is administered with calcium-fortified orange juice. The changes in Cmax and AUC have the potential to significantly decrease clinical efficacy and promote antibiotic resistance. Not warning patients about potential food-drug interactions with fortified foods may be a major unrealized and unstudied inadvertent source of clinical failures and resistance trends with fluoroquinolones. Subject total: Subjects were healthy volunteers.
Part Used : น้ำจากผลActivity : EFFECTS ON PHARMACOKINETICSolvent/Active Compound : orange juice and calcium-fortified orange juiceType of experiment : humanType of animal : -Type of study : Cross overN(Total) : 15* (M/F = 8/7)N(Treatment) : 15 (M/F = 8/7)Sex : Both sexAge : >/= 18 yrs. (mean 38.8 +/- 8.1)Route : Oral administrationDose/Conc.(herb) : A single 500 mg tablet of ciprofloxacin with 12 ounces of orange juice or orange juice fortified with calcium.Duration : Blood samples were collected predose (baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours after each ciprofloxacin administration.Type of interaction : PharmacokineticsInteraction with drug : CiprofloxacinDose/Conc.(drug) : A single 500 mg tablet of ciprofloxacinResult : PositiveRemark : Result: When the two orange juice arms were compared to each other, Cmax and AUC24 were decreased by 22% (p = 0.005) and 21% (p = 0.015) when ciprofloxacin was taken with calcium-fortified orange juice as compared to the nonfortified version.Note : Although ciprofloxacin is marginally bioequivalent when administered with orange juice, it is not when it is administered with calcium-fortified orange juice. The changes in Cmax and AUC have the potential to significantly decrease clinical efficacy and promote antibiotic resistance. Not warning patients about potential food-drug interactions with fortified foods may be a major unrealized and unstudied inadvertent source of clinical failures and resistance trends with fluoroquinolones. Subject total: Subjects were healthy volunteers.
Part Used : น้ำจากผลActivity : EFFECTS ON PHARMACOKINETICSolvent/Active Compound : orange juiceType of experiment : humanType of animal : -Type of study : Open trialN(Total) : 16* (M/F = 8/8)N(Treatment) : 16 (M/F = 8/8)Sex : Both sexAge : >/= 18 yrs. (mean+/-SD: 37.9+/-8.6)Route : Oral administrationDose/Conc.(herb) : A single 400-mg tablet of gatifloxacin with 12 ounces of commercially available orange juice. Blood samples were collected immediately prior to (baseline) drug administration and then at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours after drug administration.Duration : -Type of interaction : PharmacokineticsInteraction with drug : GatifloxacinDose/Conc.(drug) : A single 400-mg tablet of gatifloxacin.Result : NegativeRemark : Result: Athough no confidence interval range is set for tmax values, the same calculations noted an effect (183.0% [120.7%, 245.3%]) if one were to reference the guidelines for AUC and Cmax. When taken with nonfortified orange juice, similar changes were seen, but these changes were approximately 50% to 67% smaller than those seen with the calcium-fortified juice, and none of them approached significance in their differences. In terms of bioavailability, no effect was demonstrated between the nonfortified juice and water for any of the tested parameters that have breakpoint guidelines (Cmax, 94.8% [82.6%, 107.0%]: ACU, 94.6% [88.0%, 101.2%]).
Part Used : น้ำจากผลActivity : EFFECTS ON PHARMACOKINETICSolvent/Active Compound : orange juiceType of experiment : humanType of animal : -Type of study : Cross overN(Total) : 16* (M/F = 8/8)N(Treatment) : 16 (M/F = 8/8)Sex : Both sexAge : >/= 18 yrs. (mean+/-SD: 37.9+/-8.6)Route : Oral administrationDose/Conc.(herb) : A single 400-mg tablet of gatifloxacin with 12 ounces of commercially available orange juice. Blood samples were collected immediately prior to (baseline) drug administration and then at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours after drug administration.Duration : -Type of interaction : PharmacokineticsInteraction with drug : GatifloxacinDose/Conc.(drug) : A single 400-mg tablet of gatifloxacin.Result : NegativeRemark : Result: Athough no confidence interval range is set for tmax values, the same calculations noted an effect (183.0% [120.7%, 245.3%]) if one were to reference the guidelines for AUC and Cmax. When taken with nonfortified orange juice, similar changes were seen, but these changes were approximately 50% to 67% smaller than those seen with the calcium-fortified juice, and none of them approached significance in their differences. In terms of bioavailability, no effect was demonstrated between the nonfortified juice and water for any of the tested parameters that have breakpoint guidelines (Cmax, 94.8% [82.6%, 107.0%]: ACU, 94.6% [88.0%, 101.2%]).
Part Used : น้ำจากผลActivity : EFFECTS ON PHARMACOKINETICSolvent/Active Compound : calcium-fortified orange juiceType of experiment : humanType of animal : -Type of study : Open trialN(Total) : 16* (M/F = 8/8)N(Treatment) : 16 (M/F = 8/8)Sex : Both sexAge : >/= 18 yrs. (mean+/-SD: 37.9+/-8.6)Route : Oral administrationDose/Conc.(herb) : A single 400-mg tablet of gatifloxacin with 12 ounces of commercially available calcium-fortified orange juice. Blood samples were collected immediately prior to (baseline) drug administration and then at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours after drug administration.Duration : -Type of interaction : PharmacokineticsInteraction with drug : GatifloxacinDose/Conc.(drug) : A single 400-mg tablet of gatifloxacin.Result : NegativeRemark : Result: A significant increases in total oral clearance (15%) and volume of distribution (13%) along with a matching significant decrease (12%) in exposure (AUC) when gatifloxacin was taken with the fortified juice. Although not statistically significant, peak concentrations decreased by 15% and were reached (tmax) approximately 38% later when gatifloxacin was coadministered with the calcium-fortified juice. Bioavailability testing indicated that although the 90% confidence intervals (Cls) for the ratio of the geometric means of the calcium-fortified juice and water arms' AUC stayed within the range of 80% to 125%, those for Cmax did not.
Part Used : น้ำจากผลActivity : EFFECTS ON PHARMACOKINETICSolvent/Active Compound : calcium-fortified orange juiceType of experiment : humanType of animal : -Type of study : Cross overN(Total) : 16* (M/F = 8/8)N(Treatment) : 16 (M/F = 8/8)Sex : Both sexAge : >/= 18 yrs. (mean+/-SD: 37.9+/-8.6)Route : Oral administrationDose/Conc.(herb) : A single 400-mg tablet of gatifloxacin with 12 ounces of commercially available calcium-fortified orange juice. Blood samples were collected immediately prior to (baseline) drug administration and then at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours after drug administration.Duration : -Type of interaction : PharmacokineticsInteraction with drug : GatifloxacinDose/Conc.(drug) : A single 400-mg tablet of gatifloxacin.Result : NegativeRemark : Result: A significant increases in total oral clearance (15%) and volume of distribution (13%) along with a matching significant decrease (12%) in exposure (AUC) when gatifloxacin was taken with the fortified juice. Although not statistically significant, peak concentrations decreased by 15% and were reached (tmax) approximately 38% later when gatifloxacin was coadministered with the calcium-fortified juice. Bioavailability testing indicated that although the 90% confidence intervals (Cls) for the ratio of the geometric means of the calcium-fortified juice and water arms' AUC stayed within the range of 80% to 125%, those for Cmax did not.
Part Used : น้ำจากผลActivity : EFFECTS ON PHARMACOKINETICSolvent/Active Compound : fruit juiceType of experiment : humanType of animal : -Type of study : Cross overN(Total) : 10* (M/F = 7/3)N(Treatment) : 10 (M/F = 7/3)Sex : Both sexAge : 19-29 yrs.Route : Oral administrationDose/Conc.(herb) : Subjects ingested 200 mL normal-strength orange juice 3 times a day for 2 days. On the morning of day 3, 1 hour after ingestion of 200 mL orange juice, each subject ingested 100 mg celiprolol with 200 mL orange juice. In addition, 200 mL orange juice was ingested at 4, 10, 22, and 27 hours after celiprolol intake. The concentrations of celiprolol in plasma and its excretion into urine were measured up to 33 hours after its dosing. Systolic and diastolic blood pressures and heart rate were recorded up to 10 hours.Duration : 4 days and a washout of 2 weeksType of interaction : Non-specifiedInteraction with drug : CeliprololDose/Conc.(drug) : 100 mg celiprololResult : PositiveRemark : Result: Orange juice reduced the mean peak plasma concentration of celiprolol by 89% (P < .01) and the mean area under the plasma celiprolol concentration-time curve by 83% (P < .01). The time to peak concentration of celiprolol increased from 4 to 6 hours (P < .05), and the half-life was prolonged from 4.6 to 10.8 hours (P = .05) after ingestion of orange juice. Orange juice reduced the urnary excretion of celiprolol by 77% (p < .01). No significant differences were observed in the hemodynamic variables between the phases.Note : Subject total: Subjects were healthy volunteers
Part Used : น้ำจากผลActivity : EFFECTS ON PHARMACOKINETICSolvent/Active Compound : 6',7'-DihydroxybergamottinType of experiment : humanType of animal : -Type of study : Open trialN(Total) : -N(Treatment) : -Sex : -Age : -Route : Oral administrationDose/Conc.(herb) : -Duration : -Type of interaction : PharmacokineticsInteraction with drug : Ciclosporin*/Cyclosporin/Cyclosporin A/Cyclosporine/CsA/CyADose/Conc.(drug) : -Result : NegativeRemark : Subjects were healthy subjects. Result: Seville orange juice had no influence on cyclosporine disposition.Note : Conclusions: 6'7'-Dihydroxybergamottin is not responsible for the effects of grapefruit juice on cyclosporine. Because the interaction did not occur with Seville orange juice despite reduced enterocyte concentrations of CYP3A4, inhibition of P-glycoprotein activity by other compounds in grapefruit juice may be responsible. Reduced enterocyte CYP3A4 by 6',7'-dihydroxybergamottin could be important for other drugs whose bioavailability is less dependent on P-glycoprotein. Data incomplete.
Part Used : น้ำจากผลActivity : EFFECTS ON PHARMACOKINETICSolvent/Active Compound : -Type of experiment : humanType of animal : -Type of study : Cross overN(Total) : 10*N(Treatment) : 10Sex : -Age : -Route : Oral administrationDose/Conc.(herb) : *Duration : *Type of interaction : PharmacokineticsInteraction with drug : AtenololDose/Conc.(drug) : 50 mgResult : PositiveRemark : - Orange juice decreased the mean peak plasma concn. (Cmax) of atenolol by 49% (range 16-59%, P <0.01), and the mean area under the plasma atenolol concn.-time curve (AUCo-33h) by 40% (range 25-55%; P<0.01). The time of the peak concn. (tmax) and the elimination half-life (t1/2) of atenolol remained unchanged by orange juice. The amt. of atenolol excreated into urine was decreased by 38% (range 17-60%, P<(0.01), but the renal clearance remained unaltered. - Orange juice moderately interferes with the gastrointestinal absorption of atenolol.Note : Data incomplete *In randomized cross-over study with two phases and a washout of 2 wk, ten healthy volunteers took either 200 mL orange juice or water thrice daily for 3 days and twice on the fourthy day. On the morning of day 3, each subject ingested 50 mg atenolol with an addnl. amt. of either 200 mL orange juice or water.
Part Used : น้ำจากผลActivity : EFFECTS ON PHARMACOKINETICSolvent/Active Compound : orange juiceType of experiment : humanType of animal : -Type of study : Open trialN(Total) : 12*N(Treatment) : 12Sex : MaleAge : -Route : Oral administrationDose/Conc.(herb) : a single oral dose of diltiazem 180 mg with 200 mL of orange juiceDuration : -Type of interaction : P.Kinetics & P.DynamicsInteraction with drug : DiltiazemDose/Conc.(drug) : 180 mgResult : NegativeRemark : Results: The 90% Cl of the Cmax ratios for orange juice/water were 104.59 - 114.86. Similarly, the 90% Cl of the AUC0-infinity ratios for orange juice vs. water were 103.68 - 119.83. Since these values fall within the bioequivalence criteria of 80 - 120% limits, the study demonstrates absence of interaction of diltiazem with orange juice.Note : *Subject total: Subjects were healthy volunteers. Conclusions: There is no significant influence of grape juice or orange juice on the pharmacokinetics and pharmacodynamics of diltiazem. Data incomplete.
