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NCT03441815
XC8 Safety, Tolerability and Pharmacokinetics in Healthy Volunteers
Phase 1 trial testing XC8 in Asthma in 28 participants. Completed in 7 July 2015.
7 July 2015
Quick facts
| Lead sponsor | PHARMENTERPRISES LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 14 February 2015 |
| Primary completion | 7 July 2015 |
| Estimated completion | 7 July 2015 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- XC8 — full drug profile →
- Placebo
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
PHARMENTERPRISES LLC — full company profile →
Who can join
Adults 18 to 50, male only, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and tolerability of increasing doses of XC8 after single and repeated oral administration in healthy volunteers. The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break. The primary objective of the study was to evaluate the safety and tolerability profile for XC8 after single and multiple administration based on the frequency and severity of adverse events and changes in vital signs, laboratory results, electrocardiography and results of the physical examination. The secondary objective of the study was to assess pharmacokinetics of XC8.
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 NCT03441815
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of XC8
Trials testing the same drug.
- NCT06379542 — Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections · Phase 3 · recruiting
- NCT05558462 — Pharmacokinetics and Bioequivalence of XC8 10 mg and 40 mg Tablets in Fasted Volunteers · NA · completed
- NCT05294250 — Study of the Effect of Food Intake on the Bioavailability of XC8 10 mg Film-coated Tablets · Phase 1 · completed
Other recruiting trials for Asthma
Currently open trials in the same condition.
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- NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
- NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
- NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting
Other PHARMENTERPRISES LLC trials
Trials by the same sponsor.
- NCT05628116 — Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Doses o · Phase 1 · completed
- NCT04527354 — Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia · Phase 2 · completed
- NCT03830905 — Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI · Phase 2 · completed
- NCT03455491 — Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections · Phase 2 · completed
- NCT03459391 — Study to Assess Safety, Tolerability and Pharmacokinetics of XC221 in Healthy Volunteers · 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 NCT03441815 (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 PHARMENTERPRISES LLC
- Last refreshed: 22 February 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/NCT03441815.
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