trial

Bioequivalence Fasting Study in Patients

NCTId NCT02072954
as of 2026-07-01
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at a glance
Phase 2, Phase 3 · Completed
Enrollment 48 (actual)
Sponsored by Amneal Pharmaceuticals, LLC
Primary completion 2014-02
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 2, Phase 3
Status
Completed
Enrollment
48 (actual)
Study type
Interventional
Allocation
Randomized
Model
Crossover
Masking
None
Start
2013-11
Primary completion
2014-02
Eligibility
ALL · 18 Years · 65 Years

Interventions & indications

Drugs
Asenapine

Sponsors

Amneal Pharmaceuticals, LLCLead Sponsor
Accutest Research Laboratories (I) Pvt. Ltd.Collaborator

Investigators

1
Ashutosh Jani, MDPrincipal Investigator

Sites

2 total
Jūnāgadh, IndiaSurat, India

Linked catalysts

1
Bioequivalence Fasting Study in Patients — primary completion2014-02

Facts & assertions

4 sourced
Enrollment
48
Phase
PHASE2,PHASE3
Primary Completion Date
2014-02
Status
COMPLETED
relationships
The graph out of here
drug
Asenapine
drug
lead_sponsor
Amneal Pharmaceuticals, LLC
company
collaborator
Accutest Research Laboratories (I) Pvt. Ltd.
company
indication
Schizophrenia
indication
Schizophrenia
indication
investigator
Ashutosh Jani, MD
person