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Study to Compare Blood Levels of Ceftriaxone Given by Suppository or Injection.

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
Email 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
Email 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)
Willing and able to give informed consent to participate in the trial
Able, in the investigators opinion, and willing to comply with the study requirements and followup.

Exclusion Criteria:

Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
Presence of any condition which in the judgment of the investigator would affect the absorption of the rectal formulation e.g. previous surgery, haemorrhoids, inflammatory bowel disease
Irritable bowel syndrome (IBS) or diarrhoea in the 24 hours prior to study drug administration
Presence of any condition which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition).
Seropositive for HIV at screening
Hepatitis B surface antigen (HBsAg) detected in serum at screening.
Seropositive for hepatitis C virus (antibodies to HCV) at screening
Participation in a clinical trial and/or has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication and throughout the study period.
Any medical condition that in the judgment of the investigator would make the administration of the study treatments unsafe.
Use of medications known to have a potentially clinically significant interaction with ceftriaxone or with sodium chenodeoxycholate (Na-CDC) in the 28 days prior to the first dose and throughout the study period. This includes aluminium-containing antacids, colestipol, phenobarbital and the combined oral contraceptive pill.
Known 27-hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis)
History of anaphylaxis and /or hypotension, laryngeal oedema, wheezing, angioedema or urticarial rash following treatment with ceftriaxone, another cephalosporin or any beta lactam (e.g. penicillin).
History of any other clinically significant reaction to ceftriaxone, another cephalosporin or beta lactam e.g. drug induced nephritis, hepatitis, erythema multiforme that, in the opinion of the investigator, contraindicates participation in the study.
Serious chronic illness.

Abnormal baseline laboratory screening test as defined below:

AST > 2 x upper normal limit
ALT > 2 x upper normal limit
Anaemia (Hb < 11 g/dL for female and Hb < 12 g/dL for male),
Platelets < 150,000
Total bilirubin > 2 x upper normal limit
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Body Mass Index> 35
History of alcohol or substance abuse or dependence during the 6 months before study participation: History of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men. One drink is equivalent to 12 g alcohol = 5 oz (150 mL) of wine or 12 oz (360 mL) of beer or 1.5 oz (45 mL) of 80 proof distilled spirits.

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