NCT05804721

Bioequivalence Study 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)

Comparative Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence 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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: Male
• Age: 45 Years – 55 Years
• Healthy volunteers: Accepted

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: 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

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. 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%.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Apipe (Aripiprazole10 mg)	Test drug
DRUG	Abilify (Aripiprazole10 mg)	Reference drug

Timeline

• Start date: 2022-10-10
• Primary completion: 2022-11-07
• Completion: 2022-12-19
• First posted: 2023-04-07
• Last updated: 2023-04-07

Locations

1 site across 1 country: Egypt