A Phase 1 interventional study of Apipe (Aripiprazole10 mg) and Abilify (Aripiprazole10 mg) in Healthy, sponsored by Genuine Research Center, Egypt. Completed at 1 site in Egypt. Open to male participants aged 45 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by Genuine Research Center, Egypt · Phase 1, Interventional, and Other
Comparative randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Aripiprazole from Apipe 10 mg orally disintegrating tablets (Man. by: P\&C Labs (Pellets\&CR Products), Egypt) versus Abilify 10 mg orodispersible tablets (Otsuka Pharmaceutical Netherlands B.V., Netherlands ) in Healthy Human Volunteers Under Fasting Condition
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. 0.00, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 hours.
Primary Pharmacokinetic Parameters: Cmax, Truncated AUC0→72 Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax and Truncated AUC0→72 for untransformed data of Ke, tmax and t1/2e.
The confidence intervals of logarithmically transformed Test/Reference ratios for Truncated AUC0→72 and Cmax to be within 80.00-125.00%.
Genuine Research Center, Egypt is the lead sponsor of 36 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 orally disintegrating tablet contains 10 mg Aripiprazole administrated according to a randomization scheme with 240 ml of water
Drug: Apipe (Aripiprazole10 mg)
1 orodispersible tablet contains 10 mg Aripiprazole administrated according to a randomization scheme with 240 ml of water
Drug: Abilify (Aripiprazole10 mg)
Test drug
Also known as: Abilify
Reference drug
Also known as: Abilify
Cmax
to measure the maximal measured plasma concentration
Time frame: Up to 72 hours post dose in each treatment period
Tmax
time of the maximum plasma concentration
Time frame: Up to 72 hours post dose in each treatment period
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Genuine Research Center, Egypt