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Bioequivalence Fasting Study in Patients

NCT02072954 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-06-27

No results posted yet for this study

Summary

To compare and evaluate the oral bioavailability of Asenapine Sublingual Tablets, 10 mg manufactured by AMNEAL PHARMACEUTICALS, USA with SAPHRIS® (asenapine) sublingual tablets, 10 mg.

Conditions

Interventions

DRUG

Asenapine Sublingual Tablets 10 mg

White to off-white, round, uncoated,unscored, flat-faced radius edge tablet. Debossed with A on one side and 17 on the other side

DRUG

Asenapine Sublingual Tablets 10 mg

Round, white to off-white sublingual tablets, with "10" on one side within a circle

Sponsors & Collaborators

  • Accutest Research Laboratories (I) Pvt. Ltd.

    collaborator INDUSTRY

  • Amneal Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Ashutosh Jani, MD · Accutest Reserach laboratories (i) Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-02-28
Completion
2014-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02072954 on ClinicalTrials.gov