BA/BE trial of WosulinÂ® N (100 IU/mL)

A Pilot Study To Compare Bioavailability Between Wockhardtâ??s WosulinÂ® N (100 IU/mL) {Isophane Insulin Human, suspension, r- DNA origin} a nd Humulin N (100 IU/mL), In Healthy Male Subjects.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/031985

Enrollment

Registered

2021-03-15

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: WosulinÂ® N: WosulinÂ® N, (100 IU/mL) 3 ml cartridges of Wockhardt Ltd. 0.4 IU/kg body weight of study drug will be administered subcutaneously. Control Intervention1: Humulin N: Humul

Eligibility

Inclusion criteria

Inclusion criteria: -Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.

Exclusion criteria

Exclusion criteria: - Hypersensitivity to Insulin or related class of drugs. - History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.

Design outcomes

Primary

Measure	Time frame
The primary objective is to compare pharmacokinetic parameters (Cmax and AUC0-24h) of Wockhardtâ??s WosulinÂ® N (100 IU/mL) {Isophane Insulin Human, suspension, r-DNA origin} and HumulinN (100 IU/mL) in healthy adult male subjects. Timepoint: 24 hrs	—

Secondary

Measure	Time frame
The primary objective is to compare pharmacokinetic parameters (Cmax and AUC0-24h) of Wockhardtâ??s WosulinÂ® N (100 IU/mL) {Isophane Insulin Human, suspension, r-DNA origin} and HumulinN (100 IU/mL) in healthy adult male subjects. Timepoint: 24 hrs	—

Countries

India

Contacts

Public ContactDr Mushtaque Mastim

Wockhardt Limited

mmastim@wockhardt.com02226596841

Outcome results