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Comparative Bio availability of diclofenac sodium 75 mg per 1 ml injection as intravenous bolus in fasting human volunteers

A Randomized Open Label Balanced Two Treatment Two period Two Sequence Single Dose Crossover Comparative Bioavailability Study of Dynapar AQ® Diclofenac Sodium Solution for Injection 75 mg/1 ml IV Bolus of Troikaa Pharmaceuticals Ltd with Voltarol® Ampoules Diclofenac Sodium Solution for Injection, 75 mg/3 mL IV Infusion of Novartis Pharmaceuticals UK Ltd UK in Normal Healthy Adult Male Human Subjects under Fasting Conditions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018583
Enrollment
28
Registered
2019-04-12
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

None listed

Interventions

Intervention1: Dynapar AQ® Diclofenac Sodium Solution for Injection 75 mg/1 ml: Strength 75 mg/1 ml Dose 1 x 75 mg/1 ml Injection as Intravenous Bolus Troikaa Pharmaceuticals Ltd India Co

Sponsors

Troikaa Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Body Mass Index between 18.5-30 Kg / m2 extremes included 2 Subjects with normal findings as determined by baseline history physical examination and vital sign examination blood pressure pulse rate respiration rate and body temperature 3 Subjects with clinically acceptable findings as determined by haemogram biochemistry urinalysis 12 lead ECG and chest X-ray if done

Exclusion criteria

Exclusion criteria: 1 Known history of hypersensitivity to Diclofenac or related drugs 2 Requiring medication for any ailment having enzyme modifying activity in the previous 28 days prior to dosing day 3 Subjects who have taken prescription medications or over the counter products including vitamins and minerals within 14 days prior to administration of IMP

Design outcomes

Primary

MeasureTime frame
To demonstrate the Comparative Bioavailability of test product and reference productTimepoint: 30 sec to 12 hrs—

Secondary

MeasureTime frame
To monitor the safety and tolerability of a single intravenous dose of IMPsTimepoint: 30 sec to 12 hrs—

Countries

India

Contacts

Public ContactDr Alpesh Patel

Accutest Research lab pvt ltd

arlahd@accutestglobal.com07940231600

Outcome results

None listed

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