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Bioequivalence study of Pregabalin 75 mg Duloxetine 30 mg capsule

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Pregabalin 75 mg Duloxetine as delayed release 30 mg capsule of Signature Phytochemical Industries in comparison with Pregalin D 75/30 Pregabalin 75 mg Duloxetine as delayed release) 30 mg Capsule of Torrent Pharma Ltd., in healthy adult human subjects under fasting condition.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045415
Enrollment
24
Registered
2022-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

None listed

Interventions

Intervention1: FDC of Pregabalin 75 mg and Duloxetine 30 mg capsule: Single dose one time only Control Intervention1: Pregalin D 30 mg Capsule: Single dose one time only

Sponsors

Signature Phytochemical Industries
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.Male subjects have to agree to use condoms during sexual intercourse with a woman of childbearing potential for at least 10 weeks (one complete sperm cycle) after the last dose of study drug. 4.Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.

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
To evaluate the PK parameter Cmax, AUC0-t and AUC0-â??Timepoint: Day 1 to Day 11—

Secondary

MeasureTime frame
1. Monitoring of safety of IP 2. Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: Day 1 to Day 11—

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