NCT00840203 is a Phase 1 clinical trial of Rowasa® 4 gm/60 mL Rectal Enema in Healthy, sponsored by Teva Pharmaceuticals USA.

Who is sponsoring NCT00840203?

NCT00840203 is sponsored by Teva Pharmaceuticals USA.

What drugs are being tested in NCT00840203?

Interventions in NCT00840203: Rowasa® 4 gm/60 mL Rectal Enema, Mesalamine 4 gm/60 mL Rectal Enema.

Is NCT00840203 still recruiting?

NCT00840203 is currently completed. Last updated 15 August 2024.

Are results published for NCT00840203?

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

Last reviewed 2024-08-15 · How we verify

NCT00840203

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

A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 mL Rectal Enema Formulations

Completed Phase 1 Results posted Last updated 15 August 2024

What this trial tests

Phase 1 trial testing Rowasa® 4 gm/60 mL Rectal Enema in Healthy in 72 participants. Completed in 1 June 2003.

Timeline

1 May 2003

Primary endpoint
1 June 2003

1 June 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	72
Start date	1 May 2003
Primary completion	1 June 2003
Estimated completion	1 June 2003
Sites	1 location across United States

Drugs / interventions tested

Rowasa® 4 gm/60 mL Rectal Enema — full drug profile →
Mesalamine 4 gm/60 mL Rectal Enema — 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
Time frame: Blood samples collected over 48 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time frame: Blood samples collected over 48 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Time frame: Blood samples collected over 48 hour period
Bioequivalence based on AUC0-t

Sponsor's own description

The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects.

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:

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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 NCT00840203 (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: 15 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/NCT00840203.

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