Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05804721
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2023-03-27
Brief Title:
Bioequivalence Study of Aripiprazole From Apipe 10 mg Orally Disintegrating Tablets Man by PC Labs Pellets CR Products Egypt Versus Abilify 10 mg Orodispersible Tablets Otsuka Pharmaceutical Netherlands BV Netherlands
Sponsor:
Genuine Research Center Egypt
Organization:
Genuine Research Center Egypt
Study Overview
Official Title:
Comparative Randomized Single Dose Two-way Crossover Bioequivalence Study to Determine the Bioequivalence Aripiprazole From Apipe 10 mg Orally Disintegrating Tablets Man by PC Labs Pellets CR Products Egypt Versus Abilify 10 mg Orodispersible Tablets Otsuka Pharmaceutical Netherlands BV Netherlands
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparative randomized single dose two-way crossover bioequivalence study to determine the bioequivalence of Aripiprazole from Apipe 10 mg orally disintegrating tablets Man by PC Labs PelletsCR Products Egypt versus Abilify 10 mg orodispersible tablets Otsuka Pharmaceutical Netherlands BV Netherlands in Healthy Human Volunteers Under Fasting Condition
Detailed Description:
Healthy male volunteers 45-55 years of age selected from the Egyptian population fulfilling the selection criteria 24 subjects will participate in the study All dosed subject samples will be analyzed and their data will be included in the final study report 18 blood samples will be drawn in each period The total volume of blood will not exceed 200 ml throughout the whole study 000 050 100 150 200 250 300 350 400 450 500 550 600 800 1200 2400 4800 7200 hours
Primary Pharmacokinetic Parameters Cmax Truncated AUC072 Secondary Pharmacokinetic Parameters Ke tmax and t12e ANOVA using 5 significance level for transformed with the 90 confidence intervals and untransformed data of Cmax and Truncated AUC072 for untransformed data of Ke tmax and t12e
The confidence intervals of logarithmically transformed TestReference ratios for Truncated AUC072 and Cmax to be within 8000-12500
Primary Pharmacokinetic Parameters Cmax Truncated AUC072 Secondary Pharmacokinetic Parameters Ke tmax and t12e ANOVA using 5 significance level for transformed with the 90 confidence intervals and untransformed data of Cmax and Truncated AUC072 for untransformed data of Ke tmax and t12e
The confidence intervals of logarithmically transformed TestReference ratios for Truncated AUC072 and Cmax to be within 8000-12500
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None