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NCT03616301
Bioequivalence Study of Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus), and Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions
Phase 1 trial testing Clavamox in Bioequivalence in 56 participants. Completed in 13 August 2018.
13 August 2018
Quick facts
| Lead sponsor | Pharmtechnology LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 56 |
| Start date | 28 July 2018 |
| Primary completion | 13 August 2018 |
| Estimated completion | 13 August 2018 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Clavamox — full drug profile →
- Augmentin® — full drug profile →
Conditions studied
- Bioequivalence — all drugs for Bioequivalence →
Sponsor
Pharmtechnology LLC — full company profile →
Who can join
Adults 18 to 45, any sex, with Bioequivalence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject will be randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.
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:
- PubMed search for NCT03616301
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Clavamox
Trials testing the same drug.
- NCT03702894 — Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Fi · Phase 1 · completed
Other recruiting trials for Bioequivalence
Currently open trials in the same condition.
- NCT07096869 — Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Pa · Phase 1 · recruiting
Other Pharmtechnology LLC trials
Trials by the same sponsor.
- NCT06213610 — Bioequivalence Study of Perindopril Tablets in Healthy Volunteers Under Fasting Conditions · Phase 1 · unknown
- NCT05940909 — Bioequivalence Study of Perindopril /Amlodipine/Indapamide 8 mg (10 mg)/2.5 mg/10 mg Tablets in Healthy Volunteers Under · Phase 1 · unknown
- NCT05934799 — Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting · Phase 1 · completed
- NCT05685277 — Bioequivalence Study of Two Formulations of Tablets Ramipril/Hydrochlorothiazide 10 mg/25 mg in Healthy Volunteers Under · Phase 1 · completed
- NCT05642845 — Bioequivalence Study of Two Formulations of Atorvastatin Film-coated Tablets 40 mg in Healthy Volunteers Under Fasting C · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03616301 (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 Pharmtechnology LLC
- Last refreshed: 15 October 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/NCT03616301.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing