NCT01282801 is a Phase 1 clinical trial of Venlafaxine Hydrochloride in Healthy, sponsored by Teva Pharmaceuticals USA.

Who is sponsoring NCT01282801?

NCT01282801 is sponsored by Teva Pharmaceuticals USA.

What drugs are being tested in NCT01282801?

Interventions in NCT01282801: Venlafaxine Hydrochloride, Effexor® XR.

Is NCT01282801 still recruiting?

NCT01282801 is currently completed. Last updated 11 February 2011.

Are results published for NCT01282801?

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

Last reviewed 2011-02-11 · How we verify

NCT01282801

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

Randomized, 2-way Crossover, Bioequivalence Study of Venlafaxine Hydrochloride 150 mg Extended-Release Capsules and Effexor® XR 150 mg Extended-Release Capsules Administered as 1 x 150 mg Extended-Release Capsules in Healthy Subjects Under Fed Conditions.

Completed Phase 1 Results posted Last updated 11 February 2011

What this trial tests

Phase 1 trial testing Venlafaxine Hydrochloride in Healthy in 18 participants. Completed in 1 October 2002.

Timeline

1 September 2002

Primary endpoint
1 October 2002

1 October 2002

Quick facts

Lead sponsor	Teva Pharmaceuticals USA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Enrollment	18
Start date	1 September 2002
Primary completion	1 October 2002
Estimated completion	1 October 2002
Sites	1 location across Canada

Drugs / interventions tested

Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) — full drug profile →
Effexor® XR

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 of Venlafaxine.
Time frame: Blood samples collected over a 36 hour period.
Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).
AUC0-t of Venlafaxine.
Time frame: Blood samples collected over a 36 hour period.
Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
AUC0-inf of Venlafaxine.
Time frame: Blood samples collected over a 36 hour period.
Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).

Sponsor's own description

The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference) administered as 1 x 150 mg extended-release capsule under fed 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:

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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 NCT01282801 (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: 11 February 2011

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/NCT01282801.

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