Adults 18 to 40, any sex, with Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under the Curve_steady-statePrimary· Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC\_steady-state (ss) is the area under the curve during the steady-state period. The AUC\_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.
Group
Value
95% CI
Test Product
996.2436
± 546.1831
Reference Product
1038.5812
± 550.8923
Cmin_steady-statePrimary· Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
Cmin\_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state. Cmin\_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.
Group
Value
95% CI
Test Product
26.4410
± 15.7817
Reference Product
27.9625
± 15.8840
Cmax_steady-statePrimary· Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
Cmax\_steady-state (ss) is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state. Cmax\_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
Group
Value
95% CI
Test Product
61.0319
± 34.8551
Reference Product
64.3281
± 35.7439
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT03792477 — A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
· Phase 1
· completed
NCT03443089 — Comparative Bioavailability of Two Injectable Suspension Formulations of Medroxyprogesterone Acetate+Estradiol Cypionate
· Phase 1
· completed
NCT01262989 — SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin
· Phase 1
· completed
NCT01330303 — SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin
· Phase 1
· completed
Other recruiting trials for Depressive Disorder
Currently open trials in the same condition.
NCT07290153 — Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC
· recruiting
NCT07100951 — Comparing Brief Psychoanalytic Couple Therapy and Emotionally Focused Therapy in Reducing Relationship Distress
· NA
· recruiting
NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave
· recruiting
NCT06901739 — Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity.
· NA
· recruiting
NCT06724666 — Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
· NA
· recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam
· Phase 2, PHASE3
· not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose
· Phase 1
· not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH
· Phase 3
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 20 June 2018
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/NCT01316926.