Bioequivalence of SPARCs levalbuterol tartrate HFA 45 Âµg inhalation aerosol in subjects with asthma

Pharmacodynamic Bioequivalence Study of Sun Pharmaceutical Industries Ltd Levalbuterol Tartrate HFA 45 mcg Inhalation Aerosol and Xopendx (Levalbuterol Tartrate HFA Inhalation Aerosol) In Patients With Asthma: A Randomized, Double Blind, Double dummy, Four way Crossover, Four period, Four sequence, Four treatment, Single dose, Placebo and Active Controlled, Comparative, Multicentric Clinical Study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/10/006271

Enrollment

Registered

2015-10-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Asthama Health Condition 2: J459- Other and unspecified asthma

Interventions

Intervention1: Levalbuterol tartrate HFA inhalation aerosol: 45 mcg (four crossover treatment of Test 45 mcg, reference 45 mcg, reference 90 mcg and placebo at a particular dose level) Control Interve

Eligibility

Inclusion criteria

Inclusion criteria: -Men and non pregnant women asthma patients aged 18 to 65 years -Patients with diagnosis of moderate to severe asthma (based on NAEPP guidelines) for at least 6 months prior to screening visit. The patients with: Symptoms-Daily, Night time awakenings- moderate: > 1x/week but not nightly OR Severe: often 7x/week -SABA use (other than for exercise induced bronchospasm)- Daily. -Patients showing reversibility of levalbuterol tartrate -15% or more increase in FEV1, 30 min after inhalations of 2 puffs (90 Î¼g) of Xopenex HFA 45 Î¼g inhalation aerosol -5. Baseline (at check in visit) FEV1 should not be less than 45% of predicted or vary by more than +12 % from screening visit FEV1 value iv) Interference with Normal Activity- Some limitation 3. FEV1 40% to 70% (both inclusive) of predicted at screening

Exclusion criteria

Exclusion criteria: -Allergy or Significant history of hypersensitivity or idiosyncratic reactions or intolerance to levalbuterol tartrate , beta 2 receptor agonist drug, HFA and/or any related compounds etc -Patients on oral corticosteroids -Diagnosis of COPD

Design outcomes

Primary

Measure	Time frame
FEV1, FVC and PEFRTimepoint: 1 hour (Â± 10 min) prior to dosing. Post inhalation FEV1, FVC and PEFR will be done 3 times at 0.166 hrs (10 min), 0.25 hrs (15 min), 0.5 hrs (30 min), 1.0 hrs (60 min), 1.5 hrs (90 min), 2, 3, 4, 5 and 6 hour post dosing	—

Secondary

Measure	Time frame
SafetyTimepoint: Period 1: Dosing, check out; and Period 2-4: Dosing, Check-in and Check-out	—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Research Company Ltd.

clinical.trials@sparcmail.com02266455645

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026