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NCT03657550
Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects
Phase 1 trial testing Levamlodipine, Amlodipine in Hypertension in 36 participants. Completed in 6 September 2018.
6 September 2018
Quick facts
| Lead sponsor | Conjupro Biotherapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 31 May 2018 |
| Primary completion | 6 September 2018 |
| Estimated completion | 6 September 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Levamlodipine, Amlodipine — full drug profile →
- Amlodipine, Levamlodipine — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
Sponsor
Conjupro Biotherapeutics, Inc. — full company profile →
Who can join
Adults 18 to 45, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study are (1) to assess the relative bioavailability (BA) of a single oral dose of either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 mg of Amlodipine Besylate Tablet (NORVASC®) from Pfizer Inc. under fasting condition in male and female healthy subjects; and (2) to evaluate food effect on the PK profile of Levamlodipine Maleate Tablets from CSPC.
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 NCT03657550
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypertension
Currently open trials in the same condition.
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- NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
- NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
- NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting
Other Conjupro Biotherapeutics, Inc. trials
Trials by the same sponsor.
- NCT04675450 — NBP in Women With Metastatic Breast Cancer to Prevent Nab-paclitaxel Induced Toxic Neuropathy · Phase 2 · withdrawn
- NCT05043987 — Dose Escalation and Expansion Study of CPO102, an Anti-claudin 18.2 ADC in Patients With Advanced Cancers · Phase 1 · withdrawn
- NCT04853329 — Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgkins Lymphoma · Phase 1 · terminated
- NCT03567694 — Single and Multiple Doses of HA115 and Food Effect in Healthy Adult Volunteers · Phase 1 · withdrawn
- NCT04931823 — Dose Escalation and Dose Expansion Study of CPO-100 in Patients With Advanced Solid Tumors · Phase 1 · terminated
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 NCT03657550 (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 Conjupro Biotherapeutics, Inc.
- Last refreshed: 16 September 2021
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/NCT03657550.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing