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 an investigational small molecule developed by GSK plc (ticker GSK) for intestinal diseases within the gastrointestinal therapeutic area. It is being studied in a Phase 1 clinical program. Albendazole IP is also known as Albendazole IP 400 mg, reflecting the 400 mg tablet strength used in its testing.
Albendazole IP is being developed for intestinal diseases, a gastrointestinal therapeutic area. Its clinical testing has focused on this indication, with a bioequivalence study conducted in healthy adult participants. The program remains in Phase 1 development, so the drug is investigational and has not been established as a marketed treatment for any condition.
Albendazole IP is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor behind the clinical program for this small molecule candidate in intestinal diseases. GSK's development work on Albendazole IP includes a completed Phase 1 bioequivalence study conducted in India.
Albendazole IP is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. Because it is still in clinical development, Albendazole IP is investigational and has not been approved by the FDA for any indication.
Albendazole IP has been studied in one completed Phase 1 trial, NCT06201559, titled a bioequivalence study between two albendazole 400 mg tablets in healthy adult participants under fed conditions. The trial enrolled 70 participants, was randomized and controlled, and was conducted in India with healthy volunteers aged 18 years and older.