Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Albendazole IP · 1 trial · 1 indication
Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.
Blood samples were collected for PK analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.
| Arm | Type | Description |
|---|---|---|
| Sequence TRTR | EXPERIMENTAL | Participants will be administered with test (T) intervention \[Albendazole Indian Pharmacopoeia (IP) 400 mg\] in Period 1, reference (R) intervention (Albendazole Tablets 400 mg) in Period 2, T intervention in Period 3 and R intervention in Period 4. |
| Sequence RTRT | EXPERIMENTAL | Participants will be administered with reference (R) intervention in Period 1, test (T) intervention in Period 2, R intervention in Period 3 and T intervention in Period 4. |
| Name | Type | Description |
|---|---|---|
| Albendazole IP 400 mg | DRUG | Albendazole IP 400 mg tablets will be administered under fed conditions |
| Albendazole 400 mg | DRUG | Albendazole 400 mg tablets will be administered under fed conditions |
Inclusion Criteria: 1. Healthy, non-smoker, adult participants having body mass index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kilogram (kg)/ height in meter square (m2) 2. Not having any significant diseases or clinically significant abnormal findings during screening, ...
Albendazole IP is a small molecule drug being developed for intestinal diseases, a gastrointestinal therapeutic area. It is currently in Phase 1 clinical development as an investigational drug, meaning it has not been approved for marketing. Its use is being studied in the context of intestinal conditions.
Albendazole IP is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
Albendazole IP is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
Albendazole IP has one completed Phase 1 clinical trial, identified as NCT06201559. This was a bioequivalence study comparing two Albendazole 400 mg tablets in healthy adult participants under fed conditions. The trial enrolled 70 participants and was conducted in India.
Albendazole IP is a formulation of albendazole, an anthelmintic medication. The 'IP' designation may refer to a specific intellectual property or formulation. The clinical trial NCT06201559 specifically evaluates Albendazole 400 mg tablets, indicating that Albendazole IP is a tablet formulation of albendazole.