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Bioequivalence study of Sildenafil 100 mg and Dapoxetine 60 mg oral jelly 5 gm in helthy adult subjects under fasting conditions.

An open label, balanced, randomized two-treatment two-period two-sequence single oral dose crossover bioequivalence study of Sildenafil 100 mg and Dapoxetine 60 mg oral jelly 5 gm of HAB Pharmaceuticals and Research Ltd. in comparison with Super Kamagra oral Jelly (Sildenafil 100 mg and Dapoxetine 60 mg oral jelly 5 gm) of Ajanta Pharmain healthy adult male subjects under fasting condition - NIl

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048362
Enrollment
24
Registered
2022-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

None listed

Interventions

Intervention1: Sildenafil 100 mg and Dapoxetine 60 mg oral jelly 5 gm: single dose for one day only Control Intervention1: Super Kamagra oral Jelly Sildenafil 100 mg Dapoxetine 60 mg oral jelly 5 gm:

Sponsors

HAB Pharmaceuticals and Research Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 2. Willing to be available for the entire study period and to comply with protocol requirements. 3. Normal, healthy, adult, male subject of 18-45 years of age. 4. Body mass index in the range of 18 â?? 30 kg/m2. 5. Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician.

Exclusion criteria

Exclusion criteria: 1. Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs. 2. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 3. History of severe infection or major surgery in the past 6 months. 4.History of Minor surgery or fracture within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Cmax, AUC0-t and AUC0-â??Timepoint: day 1 to day 9—

Secondary

MeasureTime frame
Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: day 1 to day 9—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results

None listed

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