Clinical Trials

Several clinical trials evaluate health interventions and observational outcomes across a diverse set of conditions, including community pharmacy services, dry eye disease, premenstrual syndrome or menstrual pain, and fertility disorders such as Turner syndrome and premature ovarian failure. Sponsored by academic institutions like the University of Aarhus and Universidad de Antioquia alongside corporate entities such as Novartis Pharmaceuticals and Zenchi Inc., these protocols feature phases categorized as not applicable or unspecified. Their recruitment statuses span from not yet recruiting and actively recruiting to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06378099 Not yet recruiting
Community Pharmacy Services
Universidad de Antioquia|Farmacias Pasteur
 2024-08 Not Applicable
NCT05740579 Recruiting
Fertility Disorders|Turner Syndrome|Premature Ovarian Failure
University of Aarhus
 2023-01-01 Not Applicable
NCT06018571 Completed
Dry Eye Disease
Novartis Pharmaceuticals|Novartis
 2022-06-02 --
NCT05145257 Completed
PMS|Menstrual Pain
Zenchi Inc.|Citruslabs
 2022-03-05 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Oxytetracycline hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxytetracycline hydrochloride reversibly binds to the 30S ribosomal subunit in susceptible bacteria, blocking the attachment of aminoacyl-tRNA to the ribosomal acceptor site and thereby inhibiting bacterial protein synthesis. This disruption of translation arrests cell growth and bacterial replication, providing the pharmacological basis for treating bacterial infections and managing therapeutic protocols evaluated across clinical care and community pharmacy services.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.