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Bioequivalence study of Pregabalin(PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg) in healthy adult human subjects under fasting conditions.

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg) of Unison Pharmaceuticals Private Limited with NeuGaba® MN Tablets [Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg)] Manufactured By: Synokem Pharmaceuticals Limited; Marketed By: Sun Pharma Laboratories Limited in healthy adult human subjects under fasting conditions. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074789
Enrollment
24
Registered
2024-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

None listed

Interventions

Intervention1: Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Tablets (75 mg+1500 mcg+10 mg): Name of the drug: Pregabalin (PR), Methylcobalamin and Nortriptyline Hydrochloride Table

Sponsors

Unison Pharmaceuticals Pvt. Ltd
Lead Sponsor
Ms Unison Pharmaceuticals Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study. 2. Willing to be available for the entire study period and to comply with protocol requirements. 3. Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age. 4. Body mass index in the range of 18.5 – 30.0 kg/m2 (both inclusive). 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 conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs. 2. History 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. 5. Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction.

Design outcomes

Primary

MeasureTime frame
1.To evaluate Pharmacokinetics parameters for Nortriptyline, E-10- hydroxynortriptyline and Mecobalamine Cmax and AUC0-72. 2. To evaluate Pharmacokinetics parameters for Pregabalin Cmax, AUC0-t and AUC0-8.Timepoint: From Day 01 to Day 35—

Secondary

MeasureTime frame
1.To evaluate Pharmacokinetics parameters for Nortriptyline, E-10- hydroxynortriptyline and Mecobalamine Tmax. 2. To evaluate Pharmacokinetics parameters for Pregabalin Tmax, AUC0-t/ AUC0-8, AUC_% Extrap_obs, ?z and t1/2.Timepoint: From Day 01 to Day 35—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Private limited

harish@icbiocro.com08023641042

Outcome results

None listed

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