Studies
Study First Submitted Date | 2019-03-27 |
Study First Posted Date | 2019-03-29 |
Last Update Posted Date | 2023-07-19 |
Start Month Year | June 2024 |
Primary Completion Month Year | April 2025 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-07-19 |
Facilities
Sequence: | 199021843 |
Name | Faculty of Tropical Medicine, Mahidol University |
City | Bangkok |
Zip | 10400 |
Country | Thailand |
Facility Contacts
Sequence: | 27988184 |
Facility Id | 199021843 |
Contact Type | primary |
Name | Kittiyod Poovorawan, MD |
Kittiyod@tropmedres.ac | |
Phone | +66831496864 |
Browse Interventions
Sequence: | 95520947 | Sequence: | 95520948 | Sequence: | 95520949 |
Mesh Term | Ceftriaxone | Mesh Term | Anti-Bacterial Agents | Mesh Term | Anti-Infective Agents |
Downcase Mesh Term | ceftriaxone | Downcase Mesh Term | anti-bacterial agents | Downcase Mesh Term | anti-infective agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51900070 |
Name | Healthy |
Downcase Name | healthy |
Id Information
Sequence: | 39945643 |
Id Source | org_study_id |
Id Value | BAC18003 |
Countries
Sequence: | 42338335 |
Name | Thailand |
Removed | False |
Design Groups
Sequence: | 55310895 | Sequence: | 55310896 | Sequence: | 55310897 | Sequence: | 55310898 | Sequence: | 55310899 | Sequence: | 55310900 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | ABC | Title | ACB | Title | BAC | Title | BCA | Title | CAB | Title | CBA |
Description | A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) B. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg) C. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg) | Description | A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) C. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg) B. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg) | Description | B. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg) A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) C. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg) | Description | B. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg) C. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg) A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) | Description | C. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg) A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) B. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg) | Description | C. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg) B. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg) A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) |
Interventions
Sequence: | 52215646 | Sequence: | 52215647 | Sequence: | 52215648 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) | Name | B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg) | Name | C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg) |
Description | Parenteral ceftriaxone
Intravenous injection of 500mg of ceftriaxone sodium (Rocephin®; Roche). |
Description | Rectal ceftriaxone formulations
Formulation 1 ceftriaxone 500mg + Na-CDC 125mg hard-shell gelatin capsule |
Description | Rectal ceftriaxone formulations
Formulation 2 ceftriaxone 500mg + Na-CDC 125mg rectodispersible mannitol-based tablet |
Design Outcomes
Sequence: | 176456679 | Sequence: | 176456680 | Sequence: | 176456681 | Sequence: | 176456682 | Sequence: | 176456683 | Sequence: | 176456684 | Sequence: | 176456685 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Bioavailablity of rectal formulation | Measure | Description of Exposure (AUC0-∞) | Measure | Description of Peak concentration (Cmax) | Measure | Description of Absorption rate (Tmax) | Measure | Time above a plasma concentration of 1µg/mL (this concentration is above the MIC90 for major neonatal pathogens and is the lower limit of detection of the assay) | Measure | Occurrence of serious adverse events (SAEs) from the date of the first dose to 28 days after the final dose, according to the MedDRA classification. | Measure | Occurrence of all adverse events from the date of the first dose to 28 days after the final dose, according to the MedDRA classification. |
Time Frame | Approximately 9 months | Time Frame | Approximately 9 months | Time Frame | Approximately 100 days | Time Frame | Approximately 9 months | Time Frame | Approximately 9 months | Time Frame | Approximately 9 months | Time Frame | Approximately 9 months |
Sponsors
Sequence: | 48064075 | Sequence: | 48064076 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Oxford | Name | Biopharma (Orofino Pharmaceuticals Group) |
Overall Officials
Sequence: | 29125419 |
Role | Principal Investigator |
Name | Elizabeth Ashley, MD |
Affiliation | Mahidol Oxford Tropical Medicine Research Unit |
Central Contacts
Sequence: | 11950334 |
Contact Type | primary |
Name | Elizabeth A Ashley, MD |
Phone | +95(0)1544537 |
liz@tropmedres.ac | |
Role | Contact |
Design Group Interventions
Sequence: | 67808094 | Sequence: | 67808095 | Sequence: | 67808096 | Sequence: | 67808097 | Sequence: | 67808098 | Sequence: | 67808099 | Sequence: | 67808100 | Sequence: | 67808101 | Sequence: | 67808102 | Sequence: | 67808103 | Sequence: | 67808104 | Sequence: | 67808105 | Sequence: | 67808106 | Sequence: | 67808107 | Sequence: | 67808108 | Sequence: | 67808109 | Sequence: | 67808110 | Sequence: | 67808111 |
Design Group Id | 55310895 | Design Group Id | 55310896 | Design Group Id | 55310897 | Design Group Id | 55310898 | Design Group Id | 55310899 | Design Group Id | 55310900 | Design Group Id | 55310895 | Design Group Id | 55310896 | Design Group Id | 55310897 | Design Group Id | 55310898 | Design Group Id | 55310899 | Design Group Id | 55310900 | Design Group Id | 55310895 | Design Group Id | 55310896 | Design Group Id | 55310897 | Design Group Id | 55310898 | Design Group Id | 55310899 | Design Group Id | 55310900 |
Intervention Id | 52215646 | Intervention Id | 52215646 | Intervention Id | 52215646 | Intervention Id | 52215646 | Intervention Id | 52215646 | Intervention Id | 52215646 | Intervention Id | 52215647 | Intervention Id | 52215647 | Intervention Id | 52215647 | Intervention Id | 52215647 | Intervention Id | 52215647 | Intervention Id | 52215647 | Intervention Id | 52215648 | Intervention Id | 52215648 | Intervention Id | 52215648 | Intervention Id | 52215648 | Intervention Id | 52215648 | Intervention Id | 52215648 |
Eligibilities
Sequence: | 30604331 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 46 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Healthy male or non-pregnant female, aged 18 to 46 years (inclusive) Exclusion Criteria: Female participant who is pregnant, lactating or planning pregnancy during the course of the study. Abnormal baseline laboratory screening test as defined below: AST > 2 x upper normal limit |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253923624 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 46 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30351692 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28725061 |
Responsible Party Type | Sponsor |
Ipd Information Types
Sequence: | 3318213 |
Name | Study Protocol |