Who is sponsoring NCT00835575?

NCT00835575 is sponsored by Teva Pharmaceuticals USA.

What drugs are being tested in NCT00835575?

Interventions in NCT00835575: Mirtazapine 15 mg (Orally Disintegrating) Tablets, REMERON SolTab® 15 mg Orally Disintegrating Tablets.

Is NCT00835575 still recruiting?

NCT00835575 is currently completed. Last updated 16 August 2024.

Are results published for NCT00835575?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-16 · How we verify

NCT00835575

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Relative Bioavailability Study of 15 mg Mirtazapine Orally Disintegrating Tablets Under Fasting Conditions

Completed Phase 1 Results posted Last updated 16 August 2024

What this trial tests

Phase 1 trial testing Mirtazapine 15 mg (Orally Disintegrating) Tablets in Healthy in 32 participants. Completed in 1 August 2003.

Timeline

1 July 2003

Primary endpoint
1 August 2003

1 August 2003

Quick facts

Lead sponsor	Teva Pharmaceuticals USA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	32
Start date	1 July 2003
Primary completion	1 August 2003
Estimated completion	1 August 2003
Sites	1 location across United States

Drugs / interventions tested

Mirtazapine 15 mg (Orally Disintegrating) Tablets — full drug profile →
REMERON SolTab® 15 mg Orally Disintegrating Tablets — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Teva Pharmaceuticals USA — full company profile →

Who can join

18 and older, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 120 hour period.
Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 120 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 120 hour period.
Bioequivalence based on AUC0-inf.

Sponsor's own description

This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single oral dose (1 x 15 mg) in healthy adult subjects under fasting conditions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Teva Pharmaceuticals USA trials

Trials by the same sponsor.

NCT06742957 — Study Comparing Tapinarof Cream 1% To VTAMA ® (Tapinarof Cream 1%) In the Treatment of Plaque Psoriasis · Phase 3 · completed
NCT05617820 — Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspare · Phase 3 · completed
NCT05550337 — Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris · Phase 3 · completed
NCT04976192 — Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria · Phase 3 · completed
NCT04729621 — A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00835575 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teva Pharmaceuticals USA
Last refreshed: 16 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00835575.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing