Last reviewed · How we verify
NCT05438316
Bioequivalence Study of Two Formulations of Tablets Ramipril 10 mg in Healthy Volunteers Under Fasting Conditions
Phase 1 trial testing Ramipril tablet 10 mg in Bioequivalence in 50 participants. Completed in 17 November 2022.
2 August 2022
Quick facts
| Lead sponsor | Pharmtechnology LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 17 June 2022 |
| Primary completion | 2 August 2022 |
| Estimated completion | 17 November 2022 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Ramipril tablet 10 mg
- Tritace® tablet 10 mg — 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-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Tritace®, 10 mg tablets) or the test (Ramipril, 10 mg tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), 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 NCT05438316
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 NCT05438316 (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: 29 June 2023
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/NCT05438316.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing